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Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)

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ClinicalTrials.gov Identifier: NCT01974687
Recruitment Status : Completed
First Posted : November 1, 2013
Results First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Uprifosbuvir
Drug: Placebo
Drug: Itraconazole
Enrollment 178
Recruitment Details Per protocol, the Group D part of the study allowed to randomize Genotype 2, 3, 4, 5 and 6 Hepatitis C Virus (HCV)-infected participants, however, only Genotype 2 and 3 HCV-infected participants were enrolled.
Pre-assignment Details  
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Placebo (Cohort 6a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet) Group A: Uprifosbuvir 50 mg (Cohort 3a) Group A: Placebo (Cohorts 1a-5a - Pooled)
Hide Arm/Group Description Participants were administered a single dose of uprifosbuvir (MK-3682/IDX21437) 10 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods. Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions. Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11. Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
Period Title: Overall Study
Started 6 6 6 6 2 6 3 3 3 3 3 13 13 10 19 9 9 11 9 3 3 8 8 6 10
Treated 6 6 6 6 2 6 3 3 3 3 3 11 [1] 10 [2] 8 [1] 18 [3] 8 [3] 8 [3] 8 [2] 9 3 3 8 8 6 10
Completed 6 6 6 6 2 6 3 3 3 3 3 11 10 8 18 8 8 8 9 3 3 8 8 6 10
Not Completed 0 0 0 0 0 0 0 0 0 0 0 2 3 2 1 1 1 3 0 0 0 0 0 0 0
[1]
2 participants discontinued prior to receiving study drug
[2]
3 participants discontinued prior to receiving study drug
[3]
1 participant discontinued prior to receiving study drug
Arm/Group Title Group A: Placebo (Cohort 1a-Cohort 5a - Pooled) Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Placebo (Cohort 6a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet) Group A: Uprifosbuvir 50 mg (Cohort 3a) Total
Hide Arm/Group Description Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a). Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods. Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions. Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11. Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions. Total of all reporting groups
Overall Number of Baseline Participants 10 6 6 6 6 2 6 3 3 3 3 3 11 10 8 18 8 8 8 9 3 3 8 8 6 165
Hide Baseline Analysis Population Description
The baseline analysis population consisted of all participants who received at least one dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 6 participants 6 participants 6 participants 2 participants 6 participants 3 participants 3 participants 3 participants 3 participants 3 participants 11 participants 10 participants 8 participants 18 participants 8 participants 8 participants 8 participants 9 participants 3 participants 3 participants 8 participants 8 participants 6 participants 165 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
2
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
11
 100.0%
10
 100.0%
8
 100.0%
18
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
9
 100.0%
3
 100.0%
3
 100.0%
8
 100.0%
8
 100.0%
6
 100.0%
165
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 6 participants 6 participants 6 participants 6 participants 2 participants 6 participants 3 participants 3 participants 3 participants 3 participants 3 participants 11 participants 10 participants 8 participants 18 participants 8 participants 8 participants 8 participants 9 participants 3 participants 3 participants 8 participants 8 participants 6 participants 165 participants
35.3  (7.72) 29.2  (7.36) 33.3  (15.06) 35.5  (11.76) 35.2  (9.87) 36.0  (2.83) 35.3  (12.69) 37.0  (9.54) 42.3  (7.23) 46.7  (4.16) 43.3  (5.69) 41.3  (8.96) 41.2  (10.68) 42.7  (10.37) 44.3  (8.63) 40.1  (11.69) 43.3  (8.45) 40.5  (11.70) 40.5  (8.94) 43.7  (7.68) 57.0  (4.36) 56.3  (3.06) 49.1  (8.04) 43.1  (12.54) 31.3  (11.60) 40.47  (10.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 6 participants 6 participants 6 participants 2 participants 6 participants 3 participants 3 participants 3 participants 3 participants 3 participants 11 participants 10 participants 8 participants 18 participants 8 participants 8 participants 8 participants 9 participants 3 participants 3 participants 8 participants 8 participants 6 participants 165 participants
Female
4
  40.0%
4
  66.7%
2
  33.3%
5
  83.3%
4
  66.7%
0
   0.0%
4
  66.7%
0
   0.0%
0
   0.0%
1
  33.3%
2
  66.7%
1
  33.3%
5
  45.5%
0
   0.0%
5
  62.5%
5
  27.8%
3
  37.5%
5
  62.5%
4
  50.0%
3
  33.3%
0
   0.0%
0
   0.0%
1
  12.5%
6
  75.0%
3
  50.0%
67
  40.6%
Male
6
  60.0%
2
  33.3%
4
  66.7%
1
  16.7%
2
  33.3%
2
 100.0%
2
  33.3%
3
 100.0%
3
 100.0%
2
  66.7%
1
  33.3%
2
  66.7%
6
  54.5%
10
 100.0%
3
  37.5%
13
  72.2%
5
  62.5%
3
  37.5%
4
  50.0%
6
  66.7%
3
 100.0%
3
 100.0%
7
  87.5%
2
  25.0%
3
  50.0%
98
  59.4%
1.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered study drug, and that does not necessarily have a causal relationship with the study drug(s). An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug(s), whether or not related to study drug(s). The percentage of participants who experienced at least one AE is presented.
Time Frame Up to 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of the study drug
Arm/Group Title Group A: Placebo (Cohort 1a-Cohort 5a - Pooled) Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 50 mg (Cohort 3a) Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group A: Placebo (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 10 6 6 6 6 6 6 2 3 3 3 3 3 11 10 8 18 8 8 8 9 3 3 8 8
Measure Type: Number
Unit of Measure: Percentage of Participants
50.0 0.0 33.3 33.3 66.7 50.0 33.3 50.0 33.3 66.7 33.3 66.7 66.7 72.7 70.0 87.5 44.4 62.5 75.0 62.5 66.7 0.0 100.0 62.5 37.5
2.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Treatment-emergent Serious AE (SAE)
Hide Description An SAE was defined as any untoward medical occurrence that at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. The percentage of participants who experienced at least one SAE is presented.
Time Frame Up to 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of the study drug
Arm/Group Title Group A: Placebo (Cohort 1a-Cohort 5a - Pooled) Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 50 mg (Cohort 3a) Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group A: Placebo (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 10 6 6 6 6 6 6 2 3 3 3 3 3 11 10 8 18 8 8 8 9 3 3 8 8
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
3.Primary Outcome
Title Percentage of Participants Who Experienced a Treatment-emergent Dose-limiting Toxicity (DLT)
Hide Description A DLT was defined as any of the following events: Any SAE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 clinical AE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 confirmed laboratory abnormalities considered by the investigator to be at least reasonably or possibly related to study drug, except for asymptomatic Grade ¾ cholesterol and triglyceride; Any clinical or laboratory AE of any intensity that is considered by the investigator to be at least reasonably or possibly related to study drug that necessitates permanent discontinuation of study drug; Confirmed increase in QT interval corrected for heart rate using Fridericia's (QTcF) formula ≥60 msec over Baseline or an absolute QTcF ≥500 msec.
Time Frame Up to 13 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of the study drug
Arm/Group Title Group A: Placebo (Cohort 1a-Cohort 5a - Pooled) Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 50 mg (Cohort 3a) Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group A: Placebo (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 10 6 6 6 6 6 6 2 3 3 3 3 3 11 10 8 18 8 8 8 9 3 3 8 8
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
4.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Treatment-emergent Grade 1, 2, 3, 4 or 5 Laboratory Abnormality
Hide Description Laboratory abnormalities were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Treatment-emergent AEs (TEAEs)were graded as: Grade 1: Mild TEAE as Worst Severity; Grade 2: Moderate TEAE as Worst Severity; Grade 3: Severe TEAE as Worst Severity; Grade 4: Potentially Life-Threatening TEAE as Worst Severity; Grade 5: TEAE Leading to Death. The percentage of participants who experienced at least one Grade 1, 2, 3, 4 or 5 laboratory abnormality is presented.
Time Frame Up to 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of the study drug
Arm/Group Title Group A: Placebo (Cohort 1a-Cohort 5a - Pooled) Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 50 mg (Cohort 3a) Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group A: Placebo (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 10 6 6 6 6 6 6 2 3 3 3 3 3 11 10 8 18 8 8 8 9 3 3 8 8
Measure Type: Number
Unit of Measure: Percentage of Participants
Grade 1 50.00 0.0 16.7 16.7 50.0 33.3 33.3 50.0 0.0 66.7 33.3 66.7 66.7 45.5 60.0 37.5 33.3 0.0 37.5 25.0 33.3 0.0 100.0 12.5 0.0
Grade 2 0.0 0.0 16.7 16.7 16.7 16.7 0.0 0.0 0.0 0.0 0.0 0.0 33.3 18.2 0.0 50.0 5.6 62.5 37.5 25.0 33.3 0.0 0.0 37.5 37.5
Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 33.3 0.0 0.0 0.0 0.0 9.1 10.0 0.0 5.6 0.0 0.0 0.0 0.0 0.0 0.0 12.5 0.0
Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 12.5 0.0 0.0 0.0 0.0 0.0
Grade 5 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
5.Primary Outcome
Title Percentage of Participants Who Discontinued Study Drug Due to a Treatment-emergent AE
Hide Description The percentage of participants who discontinued study drug due to an AE is presented.
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of the study drug
Arm/Group Title Group A: Placebo (Cohort 1a-Cohort 5a - Pooled) Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 50 mg (Cohort 3a) Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group A: Placebo (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 10 6 6 6 6 6 6 2 3 3 3 3 3 11 10 8 18 8 8 8 9 3 3 8 8
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
6.Primary Outcome
Title Area Under the Plasma Drug Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics (PK) Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
0.0410
(32.7%)
0.0837
(27.9%)
1.67
(62.7%)
2.78
(37.7%)
0.246
(63.2%)
7.Primary Outcome
Title AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
1.05
(48.5%)
8.Primary Outcome
Title AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 300 mg (Cohort 6a)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
3.62
(34.0%)
Day 7
3.77
(21.7%)
9.Primary Outcome
Title AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
0.0640
(39.8%)
0.228
(49.1%)
0.341
(20.4%)
1.17 [1] 
(NA%)
1.39
(35.4%)
[1]
Not calculated
10.Primary Outcome
Title AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
0.394
(51.4%)
1.01
(52.9%)
2.80
(45.4%)
5.54
(40.1%)
Day 7
0.347
(36.2%)
0.935
(36.7%)
2.42
(46.8%)
4.59
(22.1%)
11.Primary Outcome
Title AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
2.00
(51.7%)
3.11
(45.0%)
Day 7
1.82
(43.9%)
2.88
(30.4%)
12.Primary Outcome
Title AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
1.05 [1] 
(NA%)
[1]
Not calculated
13.Primary Outcome
Title AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
3.19
(32.8%)
4.21
(35.2%)
Day 7
2.31
(31.8%)
3.51
(23.2%)
14.Primary Outcome
Title AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
10.6
(44.0%)
Day 7
9.39
(46.1%)
15.Primary Outcome
Title Maximum (Peak) Observed Plasma Drug Concentration (Cmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description Maximum observed plasma drug concentration was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
29.6
(45.3%)
47.7
(54.4%)
1120
(47.8%)
1530
(53.6%)
119
(89.2%)
16.Primary Outcome
Title Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
293
(63.0%)
17.Primary Outcome
Title Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 300 mg (Cohort 6a)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
2300
(26.6%)
Day 7
2320
(19.9%)
18.Primary Outcome
Title Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
43.6
(60.7%)
122
(26.4%)
168
(11.4%)
510 [1] 
(NA%)
667
(15.3%)
[1]
Not calculated
19.Primary Outcome
Title Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Hide Description Maximum observed plasma drug concentration was obtained. All participants were fasted.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
286
(77.1%)
524
(80.1%)
1360
(55.5%)
2320
(50.2%)
Day 7
199
(45.6%)
587
(34.9%)
1200
(59.4%)
2490
(25.7%)
20.Primary Outcome
Title Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
618
(45.2%)
778
(29.7%)
Day 7
537
(56.4%)
717
(47.2%)
21.Primary Outcome
Title Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
613 [1] 
(NA%)
[1]
Not calculated
22.Primary Outcome
Title Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
1440
(35.9%)
1090
(34.4%)
Day 7
1550
(47.5%)
929
(26.6%)
23.Primary Outcome
Title Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
2140
(39.4%)
Day 7
1910
(42.6%)
24.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description Time to maximum plasma concentration was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Median (Full Range)
Unit of Measure: hours
0.80
(0.50 to 1.05)
1.00
(0.50 to 3.00)
0.76
(0.50 to 2.00)
0.50
(0.50 to 2.00)
1.00
(0.50 to 1.00)
25.Primary Outcome
Title Tmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
3.04
(3.00 to 4.05)
26.Primary Outcome
Title Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 300 mg (Cohort 6a)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
Day 1
0.75
(0.50 to 1.00)
Day 7
0.50
(0.50 to 2.03)
27.Primary Outcome
Title Tmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Median (Full Range)
Unit of Measure: hours
0.50
(0.50 to 1.00)
1.00
(0.53 to 1.00)
1.00
(0.68 to 1.00)
0.76
(0.52 to 1.00)
1.00
(0.50 to 1.08)
28.Primary Outcome
Title Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Median (Full Range)
Unit of Measure: hours
Day 1
0.85
(0.50 to 2.03)
0.50
(0.50 to 2.00)
1.00
(0.50 to 4.00)
0.50
(0.50 to 2.00)
Day 7
0.97
(0.50 to 1.00)
0.50
(0.50 to 1.00)
0.50
(0.48 to 3.00)
0.50
(0.50 to 3.00)
29.Primary Outcome
Title Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Median (Full Range)
Unit of Measure: hours
Day 1
1.00
(0.50 to 4.00)
2.00
(0.50 to 3.00)
Day 7
0.50
(0.50 to 3.00)
0.50
(0.50 to 3.00)
30.Primary Outcome
Title Tmax of Uprifosbuvir After Singe Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: hours
0.75
(0.50 to 1.00)
31.Primary Outcome
Title Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Median (Full Range)
Unit of Measure: hours
Day 1
1.00
(0.50 to 3.00)
1.00
(0.50 to 2.00)
Day 7
1.00
(0.50 to 1.00)
1.00
(0.50 to 2.00)
32.Primary Outcome
Title Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: hours
Day 1
2.00
(1.00 to 3.00)
Day 7
1.00
(1.00 to 3.00)
33.Primary Outcome
Title Observed Terminal Half-Life (t1/2) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
0.839
(27.3%)
0.872
(33.7%)
1.05
(25.0%)
1.13
(31.6%)
0.979
(36.6%)
34.Primary Outcome
Title t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.63
(31.9%)
35.Primary Outcome
Title t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.36
(52.7%)
0.926
(34.5%)
1.09
(32.5%)
1.11 [1] 
(NA%)
1.59
(1.7%)
[1]
Not calculated
36.Primary Outcome
Title t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.04
(25.1%)
1.11
(22.5%)
154.
(34.0%)
2.58
(40.3%)
37.Primary Outcome
Title t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
2.50
(55.9%)
3.64
(54.8%)
38.Primary Outcome
Title t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.16 [1] 
(NA%)
[1]
Not calculated
39.Primary Outcome
Title t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.18
(27.2%)
2.38
(34.3%)
40.Primary Outcome
Title t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
4.30
(52.8%)
41.Primary Outcome
Title AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description Area under the drug concentration-time curve from time zero to infinity for M6, a metabolite of uprifosbuvir, estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
1.68
(47.4%)
5.01
(27.2%)
19.8
(12.7%)
29.7
(32.1%)
8.77
(8.4%)
42.Primary Outcome
Title AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
17.9
(13.4%)
43.Primary Outcome
Title AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 300 mg (Cohort 6a)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
15.1
(16.5%)
Day 7
20.6
(17.9%)
44.Primary Outcome
Title AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
2.26
(22.3%)
5.78
(4.7%)
7.31
(11.1%)
17.5 [1] 
(NA%)
33.4
(37.0%)
[1]
Not calculated
45.Primary Outcome
Title AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
4.74
(37.6%)
8.94
(20.2%)
14.4
(20.8%)
19.4
(11.1%)
Day 7
7.12
(37.6%)
12.2
(18.9%)
19.0
(16.3%)
24.4
(7.2%)
46.Primary Outcome
Title AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
14.7
(36.6%)
16.1
(23.5%)
Day 7
21.4
(26.7%)
24.7
(22.5%)
47.Primary Outcome
Title AUC0-inf of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
1.05 [1] 
(NA%)
[1]
Not calculated
48.Primary Outcome
Title AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
13.4
(22.3%)
18.4
(17.0%)
Day 7
17.5
(23.5%)
26.1
(26.5%)
49.Primary Outcome
Title AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Hide Description Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*umol/L
Day 1
13.2
(32.0%)
Day 7
23.8
(37.0%)
50.Primary Outcome
Title Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description Maximum observed plasma drug concentration was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
63.2
(19.8%)
146
(13.6%)
758
(28.2%)
1190
(16.6%)
283
(14.7%)
51.Primary Outcome
Title Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
509
(8.4%)
52.Primary Outcome
Title Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 300 mg (Cohort 6a)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
1310
(7.5%)
Day 7
1630
(14.9%)
53.Primary Outcome
Title Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
55.0
(15.0%)
170
(7.2%)
279
(5.2%)
710 [1] 
(NA%)
1210
(33.8%)
[1]
Not calculated
54.Primary Outcome
Title Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
298
(34.2%)
641
(7.6%)
1130
(22.7%)
1560
(18.9%)
Day 7
471
(33.7%)
931
(14.4%)
1420
(15.3%)
1760
(10.4%)
55.Primary Outcome
Title Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
1010
(31.5%)
1210
(21.9%)
Day 7
1420
(23.2%)
1680
(21.5%)
56.Primary Outcome
Title Cmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
597 [1] 
(NA%)
[1]
Not calculated
57.Primary Outcome
Title Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
1100
(11.5%)
1180
(11.9%)
Day 7
1550
(11.4%)
1740
(19.7%)
58.Primary Outcome
Title Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Hide Description Maximum observed plasma drug concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1
738
(31.7%)
Day 7
1180
(33.2%)
59.Primary Outcome
Title Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description Time to maximum plasma concentration was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Median (Full Range)
Unit of Measure: hours
3.01
(2.00 to 6.00)
3.50
(2.00 to 4.05)
2.53
(2.00 to 6.05)
3.50
(3.00 to 4.00)
4.00
(2.00 to 6.00)
60.Primary Outcome
Title Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
6.00
(6.00 to 8.00)
61.Primary Outcome
Title Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 300 mg (Cohort 6a)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
Day 1
3.00
(2.00 to 3.05)
Day 7
2.50
(1.00 to 4.00)
62.Primary Outcome
Title Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Median (Full Range)
Unit of Measure: hours
4.00
(4.00 to 6.00)
4.00
(3.03 to 4.00)
2.05
(2.00 to 4.00)
3.52
(3.03 to 4.00)
4.00
(1.00 to 6.00)
63.Primary Outcome
Title Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Median (Full Range)
Unit of Measure: hours
Day 1
4.00
(1.00 to 8.00)
3.00
(0.98 to 4.00)
3.00
(2.00 to 6.00)
4.00
(3.00 to 6.00)
Day 7
2.00
(1.92 to 6.00)
2.00
(1.00 to 3.00)
3.00
(1.00 to 4.00)
4.00
(2.00 to 4.00)
64.Primary Outcome
Title Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Median (Full Range)
Unit of Measure: hours
Day 1
4.00
(2.00 to 6.00)
4.00
(3.00 to 6.03)
Day 7
4.00
(2.00 to 4.00)
4.00
(3.00 to 6.00)
65.Primary Outcome
Title Tmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: hours
4.00
(4.00 to 4.00)
66.Primary Outcome
Title Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1,HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Median (Full Range)
Unit of Measure: hours
Day 1
3.00
(2.00 to 4.00)
4.00
(3.00 to 4.00)
Day 7
2.00
(2.00 to 4.00)
4.00
(2.00 to 4.00)
67.Primary Outcome
Title Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Hide Description Time to maximum plasma concentration was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: hours
Day 1
10.00
(6.00 to 23.5)
Day 7
4.00
(3.00 to 8.00)
68.Primary Outcome
Title t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
22.5
(6.2%)
24.6
(12.8%)
29.1
(15.5%)
28.8
(14.2%)
22.9
(14.0%)
69.Primary Outcome
Title t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
27.1
(9.1%)
70.Primary Outcome
Title t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 300 mg (Cohort 6a)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
32.2
(10.3%)
71.Primary Outcome
Title t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b)
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Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 3 3 3 2 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
20.1
(3.4%)
21.2
(4.8%)
21.7
(19.8%)
26.9 [1] 
(NA%)
28.0
(12.1%)
[1]
Not calculated
72.Primary Outcome
Title t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule)
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Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
25.5
(16.8%)
28.9
(15.2%)
32.6
(12.7%)
35.8
(17.8%)
73.Primary Outcome
Title t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group C: Uprifosbuvir 300 mg (Tablet) Group C: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
32.4
(7.7%)
30.8
(26.8%)
74.Primary Outcome
Title t1/2 of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 150 mg (Cohort 1e)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
24.0 [1] 
(NA%)
[1]
Not calculated
75.Primary Outcome
Title t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 3 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
27.5
(9.3%)
26.2
(24.8%)
76.Primary Outcome
Title t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)
Hide Description The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.
Time Frame Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group F: Uprifosbuvir 300 mg (Tablet)
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Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
38.9
(17.7%)
77.Primary Outcome
Title Cumulative Urine Excretion of Unchanged Uprifosbuvir in Healthy Participants (Group A)
Hide Description Cumulative urine excretion of unchanged MK-3682 in healthy participants was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: umol
0.280  (0.0800) 0.586  (0.164) 7.73  (4.67) 13.1  (4.16) 1.56  (0.397)
78.Primary Outcome
Title Cumulative Urine Excretion of Unchanged M6 in Healthy Participants (Group A)
Hide Description Cumulative urine excretion of unchanged M6 in healthy participants was obtained. All participants were fasted.
Time Frame Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).
Arm/Group Title Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Uprifosbuvir 50 mg (Cohort 3a)
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions.
Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: umol
5.93  (1.42) 15.2  (2.50) 101  (6.86) 200  (37.9) 31.8  (5.69)
79.Primary Outcome
Title Reduction in HCV RNA From Baseline on Day 8 Following Uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)
Hide Description Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-infected participants was obtained.
Time Frame Baseline and Day 8
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Hide Analysis Population Description
Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Placebo (Pooled) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet)
Hide Arm/Group Description:
Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 400 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral tablets once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 10 9 17 7 8 7 7
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Baseline 5.82  (0.879) 6.00  (0.630) 6.16  (0.633) 6.11  (0.540) 6.27  (0.485) 5.92  (0.838) 5.97  (0.739)
Day 8 0.78  (0.440) 2.49  (0.733) 4.22  (0.614) 4.39  (0.433) 0.42  (0.229) 3.34  (0.643) 4.50  (0.644)
80.Primary Outcome
Title Maximum Reduction in log10 HCV RNA From Baseline - Normal Participants (From Groups B and C) vs. Mild Hepatic Impairment Participants (Group E)
Hide Description Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype (Gt) 1, HCV-infected participants was obtained.
Time Frame Baseline and 28 days after last dose of study drug (Up to 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Group B: Uprifosbuvir 150 mg (Cohort 4b) Group C: Uprifosbuvir 300 mg (Capsule) Group E: Uprifosbuvir 450 mg
Hide Arm/Group Description:
Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions.
Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions.
Participants were administered single doses of uprifosbuvir 450 mg as oral tablets once daily for 7 days under fasted conditions.
Overall Number of Participants Analyzed 2 8 7
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Baseline Number Analyzed 2 participants 8 participants 7 participants
5.91  (0.347) 6.16  (0.633) 6.14  (0.356)
Normal hepatic fcn: Gt1a Number Analyzed 1 participants 3 participants 2 participants
0.96  (NA) 4.82  (0.504) 5.06  (0.489)
Mild hepatic impairment: Gt1a Number Analyzed 0 participants 2 participants 1 participants
2.92  (0.239) 3.60  (NA)
Normal hepatic fcn: Gt1b Number Analyzed 1 participants 5 participants 5 participants
1.35  (NA) 3.82  (0.636) 4.28  (0.584)
Mild hepatic impairment: Gt1b Number Analyzed 2 participants 1 participants 6 participants
1.36  (0.774) 3.59  (NA) 3.08  (1.06)
Normal hepatic fcn: Gt1 (pooled 1a+1b) Number Analyzed 2 participants 8 participants 7 participants
1.15  (0.274) 4.19  (0.754) 4.50  (0.644)
Mild hepatic impairment;Gt1 (pooled 1a+1b) Number Analyzed 2 participants 3 participants 7 participants
1.36  (0.774) 3.15  (0.420) 3.16  (0.989)
Time Frame Up to 42 days (28 days after last study drug administration)
Adverse Event Reporting Description Safety Population: participants who received at least one dose of the study drug. For Cohort 4a, serious AEs and nonserious AEs are presented for participants on the fasted regimen.
 
Arm/Group Title Group A: Placebo (Cohort 1a - Cohort 5a - Pooled) Group A: Uprifosbuvir 10 mg (Cohort 1a) Group A: Uprifosbuvir 25 mg (Cohort 2a) Group A: Uprifosbuvir 50 mg (Cohort 3a) Group A: Uprifosbuvir 150 mg (Cohort 4a) Group A: Uprifosbuvir 300 mg (Cohort 5a) Group A: Placebo (Cohort 6a) Group A: Uprifosbuvir 300 mg (Cohort 6a) Group B: Uprifosbuvir 10 mg (Cohort 1b) Group B: Uprifosbuvir 25 mg (Cohort 2b) Group B: Uprifosbuvir 50 mg (Cohort 3b) Group B: Uprifosbuvir 150 mg (Cohort 4b) Group B: Uprifosbuvir 300 mg (Cohort 5b) Groups C & D: Uprifosbuvir 50 mg (Capsule) Groups C & D: Uprifosbuvir 150 mg (Capsule) Groups C & D: Uprifosbuvir 250 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Capsule) Groups C & D: Uprifosbuvir 400 mg (Capsule) Groups C & D: Uprifosbuvir 300 mg (Tablet) Groups C & D: Uprifosbuvir 450 mg (Tablet) Groups C & D: Placebo (Pooled) Group E: Uprifosbuvir 150 mg (Cohort 1e) Group E: Uprifosbuvir 300 mg (Cohort 2e) Group E: Uprifosbuvir 450 mg (Cohort 3e) Group F: Uprifosbuvir 300 mg (Tablet)
Hide Arm/Group Description Participants were administered a single dose of uprifosbuvir-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of uprifosbuvir-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a). Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods. Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir-matching placebo oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered a single dose of uprifosbuvir 10 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 25 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 50 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 150 mg as oral capsules under fasted conditions. Participants were administered a single dose of uprifosbuvir 300 mg as oral capsules under fasted conditions. Participants were administered single doses of uprifosbuvir 50 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 150 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 250 mg as oral capsules once daily for 7 days under fasted conditions. Participants were administered single doses of uprifosbuvir 300 mg as oral capsules once daily for 7 days under fasted conditions. <