Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569710
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: AL-335
Drug: Odalasvir (ODV)
Drug: Simeprevir (SMV)
Enrollment 161
Recruitment Details No participants were recruited for Cohorts 10 and 12, hence no data is reported here for these two cohorts.
Pre-assignment Details  
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks. Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks. Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks. Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks. Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks. Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks. Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks. Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Period Title: Overall Study
Started 20 25 20 20 8 5 14 30 15 4
Completed 19 25 20 20 7 4 12 30 14 4
Not Completed 1 0 0 0 1 1 2 0 1 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             1             0             1             0
Virologic failure             0             0             0             0             1             0             1             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             0             0             0             0
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4) Total
Hide Arm/Group Description Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks. Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks. Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks. Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks. Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks. Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks. Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks. Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 20 25 20 20 8 5 14 30 15 4 161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 25 participants 20 participants 20 participants 8 participants 5 participants 14 participants 30 participants 15 participants 4 participants 161 participants
56
(30 to 61)
55
(29 to 64)
56
(36 to 62)
55.5
(30 to 64)
55
(41 to 60)
54
(38 to 64)
44.5
(18 to 65)
56.5
(37 to 68)
52
(36 to 67)
63.5
(61 to 69)
55
(18 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 25 participants 20 participants 20 participants 8 participants 5 participants 14 participants 30 participants 15 participants 4 participants 161 participants
Female
7
  35.0%
8
  32.0%
6
  30.0%
8
  40.0%
5
  62.5%
0
   0.0%
1
   7.1%
16
  53.3%
2
  13.3%
1
  25.0%
54
  33.5%
Male
13
  65.0%
17
  68.0%
14
  70.0%
12
  60.0%
3
  37.5%
5
 100.0%
13
  92.9%
14
  46.7%
13
  86.7%
3
  75.0%
107
  66.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 25 participants 20 participants 20 participants 8 participants 5 participants 14 participants 30 participants 15 participants 4 participants 161 participants
White
20
 100.0%
17
  68.0%
18
  90.0%
14
  70.0%
6
  75.0%
2
  40.0%
12
  85.7%
27
  90.0%
9
  60.0%
3
  75.0%
128
  79.5%
Asian
0
   0.0%
4
  16.0%
1
   5.0%
2
  10.0%
0
   0.0%
2
  40.0%
1
   7.1%
1
   3.3%
1
   6.7%
1
  25.0%
13
   8.1%
Native Hawaiian or other Pacific Islander
0
   0.0%
3
  12.0%
0
   0.0%
3
  15.0%
1
  12.5%
1
  20.0%
1
   7.1%
1
   3.3%
0
   0.0%
0
   0.0%
10
   6.2%
Multiple
0
   0.0%
1
   4.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.2%
Other
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   3.3%
5
  33.3%
0
   0.0%
8
   5.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 25 participants 20 participants 20 participants 8 participants 5 participants 14 participants 30 participants 15 participants 4 participants 161 participants
United Kingdom
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.3%
1
   6.7%
1
  25.0%
3
   1.9%
Moldova
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13
  43.3%
3
  20.0%
0
   0.0%
16
   9.9%
Mauritius
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.7%
6
  40.0%
0
   0.0%
8
   5.0%
New Zealand
20
 100.0%
25
 100.0%
20
 100.0%
20
 100.0%
8
 100.0%
5
 100.0%
14
 100.0%
14
  46.7%
5
  33.3%
3
  75.0%
134
  83.2%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Event (TEAE)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Count of Participants
Unit of Measure: Participants
17
  85.0%
19
  76.0%
14
  70.0%
13
  65.0%
7
  87.5%
4
  80.0%
13
  92.9%
17
  56.7%
10
  66.7%
4
 100.0%
2.Primary Outcome
Title Body Weight at End of Treatment
Hide Description Body weight (measured using a calibrated scale) at end of treatment was reported.
Time Frame End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 19 25 20 20 8 5 14 30 15 4
Mean (Standard Deviation)
Unit of Measure: Kilograms (kg)
76.02  (15.13) 84.58  (15.09) 80.19  (17.79) 74.07  (12.78) 73.09  (8.62) 81.30  (13.82) 81.83  (13.67) 80.15  (17.92) 86.02  (15.56) 69.90  (11.55)
3.Primary Outcome
Title Body Mass Index (BMI) at End of Treatment
Hide Description BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.
Time Frame End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 19 25 20 20 8 5 14 30 15 4
Mean (Standard Deviation)
Unit of Measure: Kilograms per square meter (Kg/m^2)
25.89  (4.63) 28.43  (4.26) 26.45  (5.53) 25.46  (3.53) 25.60  (3.21) 25.60  (2.82) 26.17  (4.20) 27.69  (5.28) 27.98  (4.37) 23.64  (4.50)
4.Primary Outcome
Title Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Hide Description Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure [sBP], Diastolic blood pressure [dBP], and Heart rate) were reported. For sBP, abnormally low: less than or equal to [<=] 90 millimeters mercury [mmHg]; Grade 1 or mild: greater than [>] 140 to less than [<] 160 mmHg; Grade 2 or moderate: >=160 to <180 and Grade 3 or severe: >=180 mmHg. For dBP, abnormally low: <=50 mmHg; Grade 1 or mild: >90 to <100 mmHg; Grade 2 or moderate: >=100 to <110 mmHg and Grade 3 or severe: >=110 mmHg. For Heart Rate, abnormally low: <=50 beats per minute [bpm] and abnormally high: >=120 bpm.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
sBP: Abnormally low 0 0 0 0 0 0 0 3.3 0 0
sBP: Grade 1 or mild 20.0 32.0 35.0 25.0 37.5 60.0 57.1 26.7 46.7 25.0
sBP: Grade 2 or moderate 10.0 8.0 0 5.0 37.5 0 7.1 20.0 13.3 50.0
sBP: Grade 3 or severe 0 4.0 5.0 0 0 0 0 3.3 13.3 0
dBP: Abnormally low 0 4.0 0 0 12.5 0 0 0 0 0
dBP: Grade 1 or mild 5.0 20.0 35.0 20.0 0 60.0 21.4 10.0 26.7 0
dBP: Grade 2 or moderate 5.0 12.0 0 0 0 0 14.3 13.3 6.7 25.0
dBP: Grade 3 or severe 0 0 0 0 25.0 0 7.1 3.3 6.7 0
Heart Rate: Abnormally low 35.0 32.0 35.0 30.0 50.0 20.0 21.4 13.3 13.3 0
Heart Rate: Abnormally high 0 0 0 0 12.5 0 0 0 0 0
5.Primary Outcome
Title Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Hide Description Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.
Time Frame Baseline up to End of treatment (up to 43 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
Decline of > 10% 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Decline of >5-<=10% 0.0 4.0 10.0 10.0 12.5 0.0 21.4 3.3 6.7 0.0
Decline of >0-<=5% 65.0 48.0 60.0 50.0 50.0 20.0 64.3 80.0 46.7 50.0
6.Primary Outcome
Title Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Hide Description Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
Hemoglobin: Grade 1 5.0 0.0 0.0 5.0 0.0 0.0 0.0 0.0 0.0 0.0
Hemoglobin: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Hemoglobin: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Hemoglobin: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Hemoglobin: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Lymphocytes: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0 0.0
Lymphocytes: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 7.1 10.0 0.0 0.0
Lymphocytes: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Lymphocytes: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Lymphocytes: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Neutrophils: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Neutrophils: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Neutrophils: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Neutrophils: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Neutrophils: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Leukocytes: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 10.0 0.0 0.0
Leukocytes: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Leukocytes: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Leukocytes: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Leukocytes: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Platelets: Grade 1 5.0 0.0 5.0 5.0 0.0 0.0 7.1 6.7 13.3 25.0
Platelets: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 16.7 0.0 0.0
Platelets: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Platelets: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Platelets: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
7.Primary Outcome
Title Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Hide Description Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
Calcium: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 3.3 13.3 0.0 0.0
Calcium: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Calcium: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Calcium: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Calcium: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Phosphate: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Phosphate: Grade 2 10.0 20.0 25.0 15.0 12.5 0.0 14.3 13.3 6.7 0.0
Phosphate: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 21.4 3.3 0.0 0.0
Phosphate: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Phosphate: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 21.4 3.3 0.0 0.0
Potassium: Grade 1 0.0 4.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0 0.0
Potassium: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Potassium: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Potassium: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Potassium: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Sodium: Grade 1 0.0 8.0 5.0 0.0 12.5 20.0 0.0 3.3 20.0 0.0
Sodium: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Sodium: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Sodium: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Sodium: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Bicarbonate: Grade 1 0.0 16.0 15.0 5.0 12.5 20.0 7.1 0.0 0.0 0.0
Bicarbonate: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0 0.0
Bicarbonate: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Bicarbonate: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Bicarbonate: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alanine aminotransferase: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Alanine aminotransferase: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alanine aminotransferase: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alanine aminotransferase: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0 0.0
Alanine aminotransferase: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0 0.0
Alkaline phosphatase: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0 0.0
Alkaline phosphatase: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alkaline phosphatase: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alkaline phosphatase: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alkaline phosphatase: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Aspartate aminotransferase: Grade: 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 25.0
Aspartate aminotransferase: Grade: 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Aspartate aminotransferase: Grade: 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0
Aspartate aminotransferase: Grade: 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Aspartate aminotransferase: Grade: 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0
Bilirubin: Grade 1 0.0 0.0 10.0 10.0 0.0 0.0 0.0 3.3 0.0 0.0
Bilirubin: Grade 2 5.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 25.0
Bilirubin: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Bilirubin: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Bilirubin: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Direct bilirubin: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Direct bilirubin: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Direct bilirubin: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 6.7 0.0
Direct bilirubin: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Direct bilirubin: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 6.7 0.0
Glucose: Grade 1 15.0 4.0 10.0 5.0 25.0 0.0 35.7 10.0 13.3 0.0
Glucose: Grade 2 0.0 4.0 5.0 0.0 12.5 0.0 14.3 13.3 13.3 25.0
Glucose: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Glucose: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Glucose: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Cholesterol: Grade 1 20.0 24.0 30.0 35.0 12.5 0.0 42.9 3.3 20.0 50.0
Cholesterol: Grade 2 15.0 8.0 5.0 5.0 37.5 0.0 0.0 6.7 6.7 0.0
Cholesterol: Grade 3 0.0 0.0 5.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Cholesterol: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Cholesterol: Grade 3+4 0.0 0.0 5.0 0.0 0.0 0.0 0.0 3.3 0.0 0.0
Triglycerides: Grade 1 5.0 16.0 10.0 15.0 50.0 20.0 28.6 16.7 33.3 25.0
Triglycerides: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 14.3 0.0 0.0 0.0
Triglycerides: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Triglycerides: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Triglycerides: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Urate: Grade 1 5.0 12.0 5.0 0.0 12.5 0.0 28.6 10.0 26.7 0.0
Urate: Grade 2 0.0 4.0 0.0 5.0 0.0 0.0 0.0 3.3 0.0 0.0
Urate: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Urate: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Urate: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Triacylglycerol lipase: Grade 1 5.0 12.0 5.0 0.0 12.5 20.0 7.1 13.3 0.0 0.0
Triacylglycerol lipase: Grade 2 15.0 4.0 10.0 0.0 12.5 0.0 7.1 3.3 0.0 0.0
Triacylglycerol lipase: Grade 3 5.0 8.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Triacylglycerol lipase: Grade 4 0.0 0.0 5.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Triacylglycerol lipase: Grade 3+4 5.0 8.0 5.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatinine: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatinine: Grade 2 0.0 0.0 0.0 5.0 0.0 0.0 7.1 0.0 0.0 0.0
Creatinine: Grade 3 0.0 0.0 0.0 0.0 12.5 0.0 0.0 3.3 0.0 0.0
Creatinine: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatinine: Grade 3+4 0.0 0.0 0.0 0.0 12.5 0.0 0.0 3.3 0.0 0.0
Creatinine clearance: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatinine clearance: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 20.0 0.0
Creatinine clearance: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatinine clearance: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatinine clearance: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Albumin: Grade 1 5.0 4.0 0.0 0.0 25.0 0.0 0.0 0.0 0.0 0.0
Albumin: Grade 2 0.0 8.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Albumin: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Albumin: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Albumin: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatine kinase: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 7.1 0.0 0.0 0.0
Creatine kinase: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 0.0
Creatine kinase: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatine kinase: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Creatine kinase: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
8.Primary Outcome
Title Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Hide Description Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
Prothrombin INR: Grade 1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Prothrombin INR: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Prothrombin INR: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Prothrombin INR: Grade 4 0.0 4.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Prothrombin INR: Grade 3+4 0.0 4.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
9.Primary Outcome
Title Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Hide Description Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
Protein: Grade 1 0.0 4.0 0.0 0.0 0.0 0.0 7.1 3.3 26.7 50.0
Protein: Grade 2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 13.3 0.0
Protein: Grade 3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 25.0
Protein: Grade 4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Protein: Grade 3+4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3 0.0 25.0
10.Primary Outcome
Title Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Hide Description Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval [QTcF], Bazett Corrected QT interval [QTcB], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (<=) QTcF increase from baseline <= 60 ms; for QTcB abnormality was defined as 30 ms <= QTcB increase from baseline <= 60 ms; for heart rate - abnormal low: <= 50 beats per minute (bpm) and abnormal high: >= 120 bpm; for QRS - abnormal high: >120 ms; for PR - abnormally low: PR < 120 ms; abnormally high - 200 ms < PR <= 240 ms and 240 ms < PR <= 300 ms.
Time Frame Up to 43 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
QTcF: Abnormal 5.0 0.0 5.0 0.0 0.0 0.0 7.1 3.3 0.0 0.0
QTcB: Abnormal 5.0 8.0 10.0 0.0 0.0 0.0 28.6 3.3 6.7 0.0
Heart rate: Abnormal low 25.0 16.0 10.0 15.0 25.0 20.0 14.3 13.3 0.0 25.0
Heart rate: Abnormal high 0.0 0.0 0.0 0.0 12.5 0.0 0.0 0.0 0.0 0.0
QRS: Abnormal high 0.0 4.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
PR: Abnormally low (PR<120 ms) 0.0 0.0 0.0 0.0 0.0 0.0 7.1 3.3 0.0 0.0
PR: Abnormally high (200 ms<PR<= 240 ms) 5.0 8.0 15.0 10.0 0.0 0.0 0.0 6.7 13.3 0.0
PR: Abnormal high (240 ms<PR<=300 ms) 10.0 0.0 0.0 0.0 0.0 0.0 7.1 0.0 0.0 0.0
11.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
Hide Description Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (<) Lower limit of quantification (LLOQ) (<15 international unit per milliliter [IU/mL]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment.
Time Frame At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
4 weeks after end of treatment
100
(83.2 to 100)
96.0
(79.6 to 99.9)
100
(83.2 to 100)
100
(83.2 to 100)
87.5
(47.3 to 99.7)
0 [1] 
(NA to NA)
71.4
(41.9 to 91.6)
100
(88.4 to 100)
93.3
(68.1 to 99.8)
100
(39.8 to 100)
12 weeks after end of treatment
100
(83.2 to 100)
84.0
(63.9 to 95.5)
100
(83.2 to 100)
100
(83.2 to 100)
87.5
(47.3 to 99.7)
0 [2] 
(NA to NA)
71.4
(41.9 to 91.6)
96.7
(82.8 to 99.9)
93.3
(68.1 to 99.8)
100
(39.8 to 100)
24 weeks after end of treatment
100
(83.2 to 100)
84.0
(63.9 to 95.5)
100
(83.2 to 100)
100
(83.2 to 100)
87.5
(47.3 to 99.7)
0 [2] 
(NA to NA)
71.4
(41.9 to 91.6)
96.7
(82.3 to 99.9)
93.3
(68.1 to 99.8)
100
(39.8 to 100)
[1]
NA indicates that upper and lower limit of confidence interval (CI) was not estimable as no participant achieved SVR in this group.
[2]
NA indicates that upper and lower limit of CI was not estimable as no participant achieved SVR in this group.
12.Secondary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Hide Description Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/ml)
AL-335 0.0  (0.0) 0.0  (0.0) 0.0  (0.0) 0.0  (0.0) 0.0  (0.0)
ALS-022399 0.000  (0.000) 0.000  (0.000) 0.308  (1.233) 0.000  (0.000) 0.280  (0.814)
ALS-022227 35.73  (13.61) 35.80  (11.15) 57.25  (31.63) 68.30  (38.33) 64.96  (28.63)
13.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Hide Description Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/mL
AL-335 414.79  (317.93) 547.36  (226.06) 563.04  (423.53) 529.17  (265.17) 677.59  (554.83)
ALS-022399 103.57  (52.25) 148.89  (48.77) 174.89  (87.05) 158.80  (55.97) 186.28  (113.18)
ALS-022227 364.4  (129.1) 392.6  (144.2) 658.0  (275.1) 643.2  (318.4) 619.7  (224.1)
14.Secondary Outcome
Title Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Hide Description Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis. Here, 'n' signifies the number of participants analyzed for specified analyte.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
AL-335 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
ALS-022399 Number Analyzed 0 participants 0 participants 6 participants 2 participants 8 participants
4.640  (4.018) 4.570  (2.899) 4.400  (2.560)
ALS-022227 Number Analyzed 11 participants 11 participants 16 participants 6 participants 27 participants
42.74  (19.26) 36.77  (10.42) 61.82  (35.47) 86.20  (56.31) 73.85  (35.15)
15.Secondary Outcome
Title Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Hide Description Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants without Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD
Cohort 6 (Participants with Cirrhosis): received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Median (Full Range)
Unit of Measure: Hours
AL-335
2.000
(0.50 to 4.00)
2.000
(1.00 to 4.00)
1.500
(1.00 to 4.00)
1.000
(1.00 to 2.00)
2.000
(0.50 to 4.00)
ALS-022399
3.0
(1.00 to 6.00)
3.000
(2.00 to 4.00)
3.000
(1.00 to 4.00)
2.000
(1.00 to 4.00)
3.000
(2.00 to 6.00)
ALS-022227
4.000
(2.00 to 4.60)
4.000
(3.00 to 6.00)
3.500
(2.00 to 6.00)
3.500
(2.00 to 6.00)
4.000
(2.00 to 6.00)
16.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Hide Description AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: nanogram*hours per milliliters (ng*h/mL)
AL-335 1049.3  (890.0) 1185.8  (502.8) 1526.3  (1328.9) 1178.5  (594.0) 1774.8  (1348.5)
ALS-022399 469.3  (224.0) 660.7  (211.5) 945.2  (551.1) 844.2  (287.9) 933.3  (544.3)
ALS-022227 2920.0  (1029.1) 3238.2  (972.8) 5258.1  (1969.4) 5218.3  (2011.9) 5425.2  (1878.2)
17.Secondary Outcome
Title Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Hide Description AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
AL-335 1058.0  (886.9) 1197.2  (507.7) 1532.7  (1329.5) 1187.3  (600.9) 1792.2  (1350.9)
ALS-022399 500.5  (230.8) 718.0  (240.7) 1009.7  (599.4) 932.7  (330.1) 1044.7  (561.1)
ALS-022227 2897.0  (1081.8) 3238.2  (972.8) 5258.1  (1969.4) 4806.0  (1945.4) 5425.2  (1878.2)
18.Secondary Outcome
Title Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
Hide Description Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
AL-335 5.931  (4.752) 7.077  (4.676) 4.983  (3.339) 5.698  (5.620) 5.811  (8.622)
ALS-022399 5.995  (1.649) 10.335  (5.558) 14.591  (10.741) 14.793  (8.738) 17.520  (10.972)
ALS-022227 38.28  (12.20) 47.26  (10.68) 67.08  (40.66) 69.18  (38.01) 72.14  (29.23)
19.Secondary Outcome
Title Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Hide Description Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Median (Full Range)
Unit of Measure: Hours
AL-335
6.000
(6.00 to 9.00)
6.000
(6.00 to 9.00)
6.000
(4.00 to 24.10)
6.025
(6.0 to 9.00)
8.670
(5.98 to 12.00)
ALS-022399
12.000
(9.00 to 12.00)
12.000
(12.00 to 12.00)
12.000
(9.00 to 24.10)
12.000
(12.00 to 12.00)
12.000
(8.50 to 24.00)
ALS-022227
24.00
(24.0 to 24.1)
24.00
(23.7 to 24.1)
24.00
(24.0 to 24.1)
24.00
(24.0 to 24.2)
23.90
(23.5 to 24.0)
20.Secondary Outcome
Title Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
Hide Description Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
121.49  (42.81) 135.20  (41.16) 218.88  (81.80) 217.17  (83.26) 227.37  (78.46)
21.Secondary Outcome
Title Cmin of Simeprevir
Hide Description Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
379.75  (247.02) 452.65  (641.99) 517.00  (416.45) 561.19  (424.71)
22.Secondary Outcome
Title Cmax of Simeprevir
Hide Description Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
1927.7  (1205.3) 1537.6  (1325.2) 1769.3  (881.6) 1925.1  (1034.0)
23.Secondary Outcome
Title Ctrough of Simeprevir
Hide Description Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
475.42  (317.63) 570.64  (816.36) 669.00  (442.50) 636.88  (455.94)
24.Secondary Outcome
Title Tmax of Simeprevir
Hide Description Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Median (Full Range)
Unit of Measure: Hours
6.000
(4.00 to 12.00)
6.000
(4.00 to 9.00)
6.000
(4.00 to 6.05)
6.000
(3.00 to 8.50)
25.Secondary Outcome
Title AUC (0-last) of Simeprevir
Hide Description AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
25018.2  (15248.7) 23061.3  (24724.4) 25266.7  (15523.4) 27070.7  (15895.7)
26.Secondary Outcome
Title AUC (0-24) of Simeprevir
Hide Description AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
25018.2  (15248.7) 23061.3  (24724.4) 25266.7  (15523.4) 27070.7  (15895.7)
27.Secondary Outcome
Title Clast of Simeprevir
Hide Description Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
402.55  (244.20) 481.76  (644.76) 538.67  (456.21) 602.60  (453.12)
28.Secondary Outcome
Title Tlast of Simeprevir
Hide Description Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Median (Full Range)
Unit of Measure: Hours
24.00
(24.0 to 24.1)
24.00
(24.0 to 24.1)
24.00
(24.0 to 24.2)
23.90
(23.5 to 24.0)
29.Secondary Outcome
Title Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
Hide Description Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
1042.8  (634.3) 960.5  (1030.7) 1053.8  (647.8) 1134.6  (666.6)
30.Secondary Outcome
Title Cmin of Odalasvir
Hide Description Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
322.45  (139.21) 97.21  (58.62) 107.90  (49.46) 102.73  (47.08) 131.31  (62.31)
31.Secondary Outcome
Title Cmax of Odalasvir
Hide Description Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
634.27  (257.29) 363.36  (184.48) 322.46  (167.29) 232.85  (187.53) 298.67  (133.99)
32.Secondary Outcome
Title Ctrough of Odalasvir
Hide Description Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
335.18  (146.14) 100.98  (61.90) 112.44  (51.53) 119.82  (58.87) 141.56  (64.81)
33.Secondary Outcome
Title Tmax of Odalasvir
Hide Description Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Median (Full Range)
Unit of Measure: Hours
6.000
(4.00 to 12.00)
6.000
(4.00 to 12.00)
6.000
(3.00 to 9.00)
4.500
(0.00 to 9.00)
6.000
(3.98 to 9.00)
34.Secondary Outcome
Title AUC (0-last) of Odalasvir
Hide Description AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
11805.5  (4902.6) 8635.5  (4656.7) 8648.1  (4161.1) 7050.0  (4001.4) 8422.2  (3617.8)
35.Secondary Outcome
Title AUC (0-24) for Odalasvir
Hide Description AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
11805.5  (4902.6) 5530.0  (2930.3) 5393.8  (2695.4) 4048.3  (2727.8) 4924.1  (2122.9)
36.Secondary Outcome
Title Clast of Odalasvir
Hide Description Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
384.09  (172.29) 162.65  (87.39) 163.54  (78.10) 131.92  (74.01) 152.47  (66.50)
37.Secondary Outcome
Title Tlast of Odalasvir
Hide Description Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Median (Full Range)
Unit of Measure: Hours
24.00
(24.0 to 24.1)
47.60
(47.5 to 47.7)
47.50
(47.4 to 47.9)
47.80
(47.4 to 48.0)
47.50
(47.5 to 47.9)
38.Secondary Outcome
Title Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
Hide Description Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Arm/Group Title Cohort 1 Cohort 1b + Cohort 4 Cohort 2 + Cohort 3 + Cohort 5 Cohort 6 Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Overall Number of Participants Analyzed 11 11 16 6 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
491.55  (203.85) 181.60  (97.99) 181.58  (87.25) 147.40  (83.86) 176.86  (75.91)
39.Secondary Outcome
Title Percentage of Participants With Virologic Relapse During the Follow-up Period
Hide Description Viral relapse is defined as participants SVR12, with HCV RNA <LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow up.
Time Frame Follow up period (Up to Week 12 after end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into study who had received at least 1 dose of any study drug, whether prematurely withdrawn from study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
0 16.0 0 0 0 100.0 14.3 3.3 0 0
40.Secondary Outcome
Title Percentage of Participants With On-treatment Failure
Hide Description On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA >= LLOQ at the actual end of study drug treatment.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0 0 12.5 0 7.1 0 0 0
41.Secondary Outcome
Title Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Hide Description Percentage of participants who achieved HCV RNA less then (<) LLOQ undetectable was reported.
Time Frame Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
Day 2 0 0 0 0 0 0 0 0 0 0
Day 3 0 0 0 5.0 0 0 0 0 6.7 0
Week 1 5.0 20.0 0 30.0 12.5 20.0 35.7 16.7 13.3 25.0
Week 2 35.0 44.0 45.0 70.0 25.0 40.0 64.3 50.0 66.7 75.0
Week 3 70.0 76.0 75.0 80.0 62.5 60.0 85.7 73.3 86.7 100
Week 4 80.0 92.0 90.0 85.0 87.5 60.0 92.9 80.0 86.7 100
Week 5 100 96.0 100 90.0 100 80.0 92.9 90.0 100 100
Week 6 90.0 100 85.0 90.0 100 100 92.9 96.7 100 100
Week 7 90.0 96.0 95.0 NA [1]  100 80.0 85.7 100 100 100
Week 8 95.0 100 100 NA [1]  87.5 100 85.7 100 93.3 100
Week 9 NA [2]  NA [2]  NA [2]  NA [1]  87.5 NA [2]  92.9 NA [2]  93.3 100
Week 10 NA [2]  NA [2]  NA [2]  NA [1]  87.5 NA [2]  92.9 NA [2]  93.3 100
Week 11 NA [2]  NA [2]  NA [2]  NA [1]  87.5 NA [2]  92.9 NA [2]  86.7 100
Week 12 NA [2]  NA [2]  NA [2]  NA [1]  87.5 NA [2]  85.7 NA [2]  93.3 100
End of treatment 95.0 100 100 90.0 87.5 100 85.7 100 93.3 100
[1]
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
[2]
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
42.Secondary Outcome
Title Percentage of Participants Who Achieved HCV RNA <LLOQ
Hide Description Percentage of participants who achieved HCV RNA <LLOQ was reported.
Time Frame Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 20 25 20 20 8 5 14 30 15 4
Measure Type: Number
Unit of Measure: Percentage of participants
Day 2 0 0 0 0 0 0 0 0 0 0
Day 3 0 0 0 0 0 0 0 0 0 0
Week 1 0 8.0 0 10.0 0 0 14.3 16.7 13.3 25.0
Week 2 20.0 20.0 15.0 40.0 0 20.0 42.9 50.0 66.7 75.0
Week 3 40.0 40.0 45.0 65.0 37.5 60.0 50.0 73.3 86.7 100
Week 4 55.0 52.0 60.0 80.0 62.5 40.0 78.6 80.0 86.7 100
Week 5 75.0 96.0 85.0 85.0 75.0 80.0 85.7 90.0 100 100
Week 6 80.0 88.0 85.0 80.0 87.5 80.0 92.9 96.7 100 100
Week 7 80.0 92.0 95.0 NA [1]  87.5 80.0 85.7 100 100 100
Week 8 85.0 96.0 100 NA [1]  87.5 100 85.7 100 93.3 100
Week 9 NA [2]  NA [2]  NA [2]  NA [1]  87.5 NA [2]  92.9 NA [2]  93.3 100
Week 10 NA [2]  NA [2]  NA [2]  NA [1]  87.5 NA [2]  92.9 NA [2]  93.3 100
Week 11 NA [2]  NA [2]  NA [2]  NA [1]  87.5 NA [2]  92.9 NA [2]  86.7 100
Week 12 NA [2]  NA [2]  NA [3]  NA [1]  87.5 NA [2]  78.6 NA [2]  93.3 100
End of treatment 85.0 96.0 100 80.0 87.5 100 78.6 100 93.3 100
[1]
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
[2]
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
[3]
NA indicates that the data was not estimable for the specified timepoint.
43.Secondary Outcome
Title Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA
Hide Description Time to achieve undetectable HCV RNA or < LLOQ HCV RNA was reported.
Time Frame Up to Week 24 (follow up visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Data was not collected and analyzed for this outcome measure as per the change in planned analysis.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
44.Secondary Outcome
Title Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
Hide Description Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure.
Time Frame Up to Week 24 (Follow up visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Participants who had virologic failure were included in this outcome measure.
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description:
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Overall Number of Participants Analyzed 0 4 0 0 1 5 3 1 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
1
 100.0%
0
   0.0%
2
  66.7%
1
 100.0%
Time Frame Up to 43 weeks
Adverse Event Reporting Description Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
 
Arm/Group Title Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Hide Arm/Group Description Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks. Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks. Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks. Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks. Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks. Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks. Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
All-Cause Mortality
Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/25 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/8 (0.00%)   0/5 (0.00%)   0/14 (0.00%)   0/30 (0.00%)   0/15 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   2/25 (8.00%)   0/20 (0.00%)   0/20 (0.00%)   0/8 (0.00%)   0/5 (0.00%)   0/14 (0.00%)   1/30 (3.33%)   2/15 (13.33%)   1/4 (25.00%) 
Cardiac disorders                     
Atrioventricular Block Second Degree * 1  1/20 (5.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
General disorders                     
Pain * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  1/30 (3.33%)  0/15 (0.00%)  0/4 (0.00%) 
Infections and infestations                     
Cellulitis * 1  0/20 (0.00%)  1/25 (4.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Pneumonia * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  1/4 (25.00%) 
Injury, poisoning and procedural complications                     
Fall * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  1/15 (6.67%)  0/4 (0.00%) 
Investigations                     
Alanine Aminotransferase Increased * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  1/15 (6.67%)  0/4 (0.00%) 
Aspartate Aminotransferase Increased * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  1/15 (6.67%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Transitional Cell Carcinoma Urethra * 1  0/20 (0.00%)  1/25 (4.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 2 (8 Weeks GT1) Cohort 3 (6 Weeks GT1) Cohort 4 (12 Weeks GT1) Cohort 5a (8 Weeks GT3) Cohort 5b (12 Weeks GT3) Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 9 (12 Weeks GT1 F4) Cohort 11 (12 Weeks GT2 F4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/20 (85.00%)   20/25 (80.00%)   14/20 (70.00%)   14/20 (70.00%)   7/8 (87.50%)   4/5 (80.00%)   13/14 (92.86%)   18/30 (60.00%)   10/15 (66.67%)   4/4 (100.00%) 
Blood and lymphatic system disorders                     
Anaemia * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  1/15 (6.67%)  0/4 (0.00%) 
Lymphadenopathy * 1  1/20 (5.00%)  0/25 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Cardiac disorders                     
Atrioventricular Block First Degree * 1  1/20 (5.00%)  1/25 (4.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Palpitations * 1  1/20 (5.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/8 (12.50%)  0/5 (0.00%)  0/14 (0.00%)  1/30 (3.33%)  0/15 (0.00%)  0/4 (0.00%) 
Supraventricular Tachycardia * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/8 (12.50%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Congenital, familial and genetic disorders                     
Porphyria Non-Acute * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  1/4 (25.00%) 
Ear and labyrinth disorders                     
Ear Discomfort * 1  1/20 (5.00%)  1/25 (4.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Ear Pruritus * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  1/4 (25.00%) 
Eye disorders                     
Dry Eye * 1  0/20 (0.00%)  1/25 (4.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  1/4 (25.00%) 
Erythema of Eyelid * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  1/30 (3.33%)  0/15 (0.00%)  0/4 (0.00%) 
Eye Irritation * 1  0/20 (0.00%)  0/25 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Eye Pruritus * 1  1/20 (5.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  1/5 (20.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Vision Blurred * 1  0/20 (0.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  1/4 (25.00%) 
Visual Impairment * 1  1/20 (5.00%)  0/25 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/5 (0.00%)  0/14 (0.00%)  0/30 (0.00%)  0/15 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders