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
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Study Type | Interventional |
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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 |
Participant Flow
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) |
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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
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Baseline Characteristics
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 | |
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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 | |
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The baseline analysis population consisted of all participants who received at least one dose of study drug.
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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 |
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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 |
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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%
|
Outcome Measures
Adverse Events