Clincosm LogoSign in Get a demo

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

Sponsor
Alios Biopharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02569710
Collaborator
(none)
161
Enrollment
11
Locations
8
Arms
30.3
Actual Duration (Months)
14.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
161 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, With or Without Simeprevir, in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Infection With or Without Compensated Child Pugh A Cirrhosis
Actual Study Start Date :
Oct 31, 2015
Actual Primary Completion Date :
May 11, 2018
Actual Study Completion Date :
May 11, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV

Treatment-naïve non-cirrhotic Hepatitis C virus (HCV)-infected participants will receive AL-335 and Odalasvir (ODV) with Simeprevir (SMV) for 8 weeks.

Drug: AL-335
AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

Drug: Odalasvir (ODV)
ODV capsules will be administered in a dose range of 25 to 50 mg.
Other Names:
  • ACH-3102

    • Drug: Simeprevir (SMV)
    SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
    Experimental: Cohort 1b (Without Cirrhosis) : AL-335+ODV

    Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV for 8 weeks.

    Drug: AL-335
    AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

    Drug: Odalasvir (ODV)
    ODV capsules will be administered in a dose range of 25 to 50 mg.
    Other Names:
  • ACH-3102

    		•
    Experimental: Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV

    Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV for 6 weeks.

    Drug: AL-335
    AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

    Drug: Odalasvir (ODV)
    ODV capsules will be administered in a dose range of 25 to 50 mg.
    Other Names:
  • ACH-3102

    • Drug: Simeprevir (SMV)
    SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
    Experimental: Cohort 4 (Without Cirrhosis) : AL-335+ODV

    Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV up to 8 or 12 weeks.

    Drug: AL-335
    AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

    Drug: Odalasvir (ODV)
    ODV capsules will be administered in a dose range of 25 to 50 mg.
    Other Names:
  • ACH-3102

    		•
    Experimental: Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV

    Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV up to 8 or 12 weeks.

    Drug: AL-335
    AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

    Drug: Odalasvir (ODV)
    ODV capsules will be administered in a dose range of 25 to 50 mg.
    Other Names:
  • ACH-3102

    • Drug: Simeprevir (SMV)
    SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
    Experimental: Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV

    Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 8 weeks.

    Drug: AL-335
    AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

    Drug: Odalasvir (ODV)
    ODV capsules will be administered in a dose range of 25 to 50 mg.
    Other Names:
  • ACH-3102

    • Drug: Simeprevir (SMV)
    SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
    Experimental: Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV

    Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 12 weeks.

    Drug: AL-335
    AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

    Drug: Odalasvir (ODV)
    ODV capsules will be administered in a dose range of 25 to 50 mg.
    Other Names:
  • ACH-3102

    • Drug: Simeprevir (SMV)
    SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
    Experimental: Cohorts 12 to 15: AL-335+ODV With/without SMV

    Based on safety, pharmacokinetic (PK), and viral load data, the treatment duration (4 to 12 weeks) and dose levels (AL-335: 400-1,200 milligram [mg], ODV: 25-50 mg with/without SMV: 75-150 mg) may be changed for ongoing and future cohorts (up to 15) after obtaining agreement from the Sponsor and the Principal Investigator.

    Drug: AL-335
    AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

    Drug: Odalasvir (ODV)
    ODV capsules will be administered in a dose range of 25 to 50 mg.
    Other Names:
  • ACH-3102

    • Drug: Simeprevir (SMV)
    SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment Emergent Adverse Event (TEAE) [Up to 43 weeks]

      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.

    2. Body Weight at End of Treatment [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)]

      Body weight (measured using a calibrated scale) at end of treatment was reported.

    3. Body Mass Index (BMI) at End of Treatment [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)]

      BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.

    4. Percentage of Participants With Worst Post-Baseline Values of Vital Signs [Up to 43 weeks]

      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.

    5. Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction [Baseline up to End of treatment (up to 43 weeks)]

      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.

    6. Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters [Up to 43 weeks]

      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.

    7. Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters [Up to 43 weeks]

      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.

    8. Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) [Up to 43 weeks]

      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.

    9. Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) [Up to 43 weeks]

      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.

    10. Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters [Up to 43 weeks]

      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.

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment [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)]

      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.

    2. Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) [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)]

      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).

    3. Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) [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)]

      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).

    4. Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) [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)]

      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).

    5. Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) [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)]

      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).

    6. 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) [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)]

      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).

    7. Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) [Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose]

      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).

    8. Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) [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)]

      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).

    9. Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) [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)]

      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).

    10. Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227 [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)]

      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).

    11. Cmin of Simeprevir [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)]

      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).

    12. Cmax of Simeprevir [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)]

      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).

    13. Ctrough of Simeprevir [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)]

      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).

    14. Tmax of Simeprevir [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)]

      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).

    15. AUC (0-last) of Simeprevir [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)]

      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).

    16. AUC (0-24) of Simeprevir [Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose]

      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).

    17. Clast of Simeprevir [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)]

      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).

    18. Tlast of Simeprevir [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)]

      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).

    19. Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir [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)]

      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).

    20. Cmin of Odalasvir [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)]

      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).

    21. Cmax of Odalasvir [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)]

      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).

    22. Ctrough of Odalasvir [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)]

      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).

    23. Tmax of Odalasvir [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)]

      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).

    24. AUC (0-last) of Odalasvir [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)]

      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).

    25. AUC (0-24) for Odalasvir [Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose]

      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).

    26. Clast of Odalasvir [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)]

      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).

    27. Tlast of Odalasvir [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)]

      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).

    28. Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir [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)]

      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).

    29. Percentage of Participants With Virologic Relapse During the Follow-up Period [Follow up period (Up to Week 12 after end of treatment)]

      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.

    30. Percentage of Participants With On-treatment Failure [Up to 12 weeks]

      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.

    31. Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable [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)]

      Percentage of participants who achieved HCV RNA less then (<) LLOQ undetectable was reported.

    32. Percentage of Participants Who Achieved HCV RNA <LLOQ [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)]

      Percentage of participants who achieved HCV RNA <LLOQ was reported.

    33. Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA [Up to Week 24 (follow up visit)]

      Time to achieve undetectable HCV RNA or < LLOQ HCV RNA was reported.

    34. Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure [Up to Week 24 (Follow up visit)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participant has provided written consent

    2. In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned

    3. Male or female, 18-70 years of age

    4. Body mass index (BMI) 18-35 kilogram per meter square (kg/m^2), inclusive

    5. A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening

    6. Female participants must either:

    • not be of childbearing potential defined as: i. Postmenopausal for at least 12 months (that is [i.e.], 2 years of amenorrhea without an alternative medical cause) and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (per reference laboratory), OR ii. Surgically sterile (example [e.g.], underwent total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant, OR

    • be of childbearing potential AND

    • not heterosexually active (e.g., abstinent or homosexual) from screening until 6 months after study drug administration (or longer, if dictated by local regulations), OR

    • if heterosexually active

    • have a vasectomized partner (confirmed sterile per verbal account of the participant), OR

    • using an acceptable method of birth control from screening and agree to continue to use the same method of contraception throughout the study and for 6 months after study drug administration (or longer, if dictated by local regulations). Oral hormone based contraceptives are not allowed from 14 days before the planned study drug administration until 6 months after the last dose of treatment due to the potential for drug-drug interactions which might undermine their efficacy. An intrauterine device (IUD), being either hormonal (i.e., Intra-Uterine System [IUS*]) or non-hormonal, is considered highly effective and reliable; therefore participants using an IUD/IUS are not required to use additional contraceptive methods (no double-barrier method is required). Other non-oral hormone-based contraception methods (e.g., injectable, implants, transdermal system, vaginal ring) may be continued, but as the interaction of the study drug with hormone-based contraception is unknown, these methods are not considered to be reliable and therefore participants should use a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide).

    • An IUS does not rely on systemic plasma concentrations and is therefore not expected to be impacted by a potential drug-drug interaction (DDI)

    Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.

    Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction

    1. A post-menopausal female who is receiving hormone replacement therapy and is willing to discontinue hormone therapy 30 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation.

    • Male participants must either:

    • be surgically sterile (had a vasectomy), or otherwise incapable of fathering a child, OR

    • not be heterosexually active (e.g., abstinent or homosexual) from enrollment (Day

    1. in the study until at least 6 months after study drug administration, OR

    • if heterosexually active:

    • have a partner who is postmenopausal (2 years amenorrhea), surgically sterile (e.g., has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant OR

    • be practicing an acceptable method of birth control from enrollment in the study (Day 1) and agree to continue to use the same method of contraception throughout the study and for at least 6 months after study drug administration (or longer, if dictated by local regulations). An acceptable method of birth control for male participants is a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide).

    Note: Male participants with a female partner who uses hormonal contraceptives (oral, injectable, implants) or a hormonal (IUS) or non-hormonal IUD and male participants who are vasectomized or otherwise incapable of fathering a child are not required to use additional contraceptive methods.

    Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.

    Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.

    NOTE: Contraceptive use by men and women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria

    1. Participants must agree to refrain from sperm/egg donation from start of dosing through 6 months after the completion of study drug administration

    2. Genotype (GT) 1a or 1b or GT2 or 3 chronic hepatitis C (CHC), depending on cohort, with positive Hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA) at screening including documentation of CHC infection for at least 6 months. Genotype testing must occur at a screening visit. NOTE: GT1 patients are eligible for inclusion even if they cannot be successfully subtyped unless a specific subtype is required for a cohort

    3. Screening HCV RNA viral load greater than or equal to (>=) 50,000 International Units per milliliter (IU/mL), except for participants with compensated cirrhosis (Child Pugh Class A) who may have HCV RNA viral load >=10^4 IU/mL

    4. No prior treatment for CHC (defined as no prior exposure to any approved or investigational drug including direct-acting antivirals, and interferon-based treatments)

    5. Fibroscan, collected within 6 months of baseline visit, with liver stiffness score less than or equal to (<=) 12.5 kilo Pascal (kPa) to be eligible (except for participants with cirrhosis, see below).

    • participants with compensated cirrhosis must meet the Child-Pugh Class A definition (see Appendix G) and at least one of the following criteria: i. Liver biopsy result indicating the presence of cirrhosis (e.g., Metavir F4; Ishak >5) or ii. Fibroscan evaluation with a liver stiffness score >12.5 kPa

    1. Participant is otherwise in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG)

    2. Willing to avoid prolonged sun exposure and use of tanning devices while taking Simeprevir (SMV) and through 4 weeks of follow up. Participant should also be advised to use a broad-spectrum sunscreen and lip balm of at least sun protection factor >30 to help protect against potential sunburn

    Exclusion Criteria:

    1. Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the end of treatment [EOT]), or breast-feeding female participant, or male participant whose female partner is pregnant or planning on becoming pregnant (during treatment and up to 6 months after the EOT)

    2. Other than CHC with or without compensated cirrhosis, clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor

    3. History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant ECG abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening

    4. Screening echocardiogram ejection fraction <55 percentage (%) or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy

    5. Creatinine clearance of <60 mL/min (Cockcroft-Gault)

    6. Positive test for Hepatitis A virus immunoglobulin (HAV) Immunoglobulin M (IgM), Hepatitis B surface antigen (HBsAg), or Human Immunodeficiency Virus (HIV) Ab

    7. Abnormal screening laboratory results that are considered clinically significant by the investigator

    8. History of clinical hepatic decompensation, e.g., variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within last year)

    9. Any condition that, in the opinion of the investigator, would compromise the study's objectives or the well-being of the participant or prevent the participant from meeting the study requirements

    10. Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication

    11. Clinically significant abnormal screening ECG findings (e.g., PR >200 msec, QRS interval >120 millisecond (msec) or corrected QT interval (QTc) >450 msec for male participants and >470 msec for female participants), based on an average of triplicate ECGs. Any evidence of heart block or bundle branch block is also exclusionary

    12. History or family history of abnormal ECG intervals, for example prolonged QT syndrome (torsade de pointes) or sudden cardiac death

    13. The participant has a positive prestudy drug screen, including methadone unless the drug is prescribed by the participant's physician. The list of drugs that should be screened for includes amphetamines, barbiturates, cocaine, opiates, phencyclidine (PCP), and benzodiazepines

    14. Laboratory abnormalities including:

    • Hematocrit <0.34

    • White blood cell counts <3,500/millimeter (mm)3 (<1,000/mm3 for participants with compensated cirrhosis)

    • Absolute neutrophil count <1,000/mm3 (<750/mm3 for participants with compensated cirrhosis)

    • Platelets <=120,000/mm3 (platelets ≤90,000/mm3 for participants with compensated cirrhosis)

    • Glycosylated hemoglobin (HbA1C) >55 mmol/mol

    • Prothrombin time >=1.5 * upper limit of normal (ULN)

    • Albumin <=32 gram per liter (g/L), bilirubin >=1.5 milligram per deciliter (mg/dL) at screening (participants with documented Gilbert's disease allowed)

    • Serum ALT concentration >=5* ULN

    • CK >1.5* ULN A single repeat laboratory evaluation under appropriate conditions (e.g., fasted, no antecedent exercise) is allowed for eligibility determination

    1. Any condition possibly affecting drug absorption (e.g., gastrectomy or other significant gastrointestinal tract surgery, such as gastroenterostomy, small bowel resection, or active enterostomy)

    2. Clinically significant blood loss or elective blood donation of significant volume (i.e., >500 mL) within 60 days of first dose of study drug; >1 unit of plasma within 7 days of first dose of study drug

    3. Evidence of clinically relevant active infection that would interfere with study conduct or its interpretation

    4. History of regular alcohol intake >10 standard drinks per week of alcohol for females and >15 standard drinks per week for males (one unit is defined as 10 g alcohol) within 3 months of the screening visit

    5. The use of prohibited medications, including prescription, over the counter (OTC) medications, herbal medications, inducers or inhibitors of Cytochrome P450 (CYP450) enzymes or drug transporters (including P-gp) within 14 days prior to the first dose of study medication is excluded, unless previously approved by the Sponsor's Medical Monitor. NOTE: Chronic medication use is permitted so long as they are medically necessary, deemed acceptable by the Principal Investigator and Medical Monitor, and not Prohibited Medications (see Section 5.12)

    6. Hypersensitivity to the active substances (including sulfa allergy) or to any of the excipients of AL-335, Odalasvir (ODV) or SMV

    7. Evidence on recent (within 6 months) liver ultrasound of hepatic mass or lesion concerning for malignancy (participants with cirrhosis only)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CAP Research Ltd Phoenix Mauritius
    2 Republican Clinical Hospital Chisinau Moldova, Republic of
    3 Auckland Clinical Studies Auckland New Zealand 1150
    4 Christchurch Clinical Studies Trust Christchurch New Zealand 8011
    5 Waikato Hospital Hamilton New Zealand
    6 P3 Research Ltd - Hawkes Bay Havelock North New Zealand
    7 P3 Research Ltd - Wellington Wellington New Zealand
    8 Wellington Hospital Wellington New Zealand
    9 King's College Hospital Brixton United Kingdom
    10 NHS Greater Glasgow and Clyde Glasgow Royal Infirmary Glasgow United Kingdom
    11 Pennine Acute Hospitals Trust Oldham United Kingdom

    Sponsors and Collaborators

    • Alios Biopharma Inc.

    Investigators

    • Study Director: Alios Biopharma Inc. Clinical Trial, Alios Biopharma Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alios Biopharma Inc.
    ClinicalTrials.gov Identifier:
    NCT02569710
    Other Study ID Numbers:
    • AL-335-604
    First Posted:
    Oct 7, 2015
    Last Update Posted:
    Jul 16, 2019
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Hepatitis, Chronic
    Simeprevir
    Odalasvir

    Study Results

    Participant Flow

    Recruitment Details No participants were recruited for Cohorts 10 and 12, hence no data is reported here for these two cohorts.
    Pre-assignment Detail
    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)
    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

    Baseline Characteristics

    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
    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 Participants 20 25 20 20 8 5 14 30 15 4 161
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    56
    55
    56
    55.5
    55
    54
    44.5
    56.5
    52
    63.5
    55
    Sex: Female, Male (Count of Participants)
    Female
    7
    35%
    8
    32%
    6
    30%
    8
    40%
    5
    62.5%
    0
    0%
    1
    7.1%
    16
    53.3%
    2
    13.3%
    1
    25%
    54
    33.5%
    Male
    13
    65%
    17
    68%
    14
    70%
    12
    60%
    3
    37.5%
    5
    100%
    13
    92.9%
    14
    46.7%
    13
    86.7%
    3
    75%
    107
    66.5%
    Race/Ethnicity, Customized (Count of Participants)
    White
    20
    100%
    17
    68%
    18
    90%
    14
    70%
    6
    75%
    2
    40%
    12
    85.7%
    27
    90%
    9
    60%
    3
    75%
    128
    79.5%
    Asian
    0
    0%
    4
    16%
    1
    5%
    2
    10%
    0
    0%
    2
    40%
    1
    7.1%
    1
    3.3%
    1
    6.7%
    1
    25%
    13
    8.1%
    Native Hawaiian or other Pacific Islander
    0
    0%
    3
    12%
    0
    0%
    3
    15%
    1
    12.5%
    1
    20%
    1
    7.1%
    1
    3.3%
    0
    0%
    0
    0%
    10
    6.2%
    Multiple
    0
    0%
    1
    4%
    0
    0%
    1
    5%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    1.2%
    Other
    0
    0%
    0
    0%
    1
    5%
    0
    0%
    1
    12.5%
    0
    0%
    0
    0%
    1
    3.3%
    5
    33.3%
    0
    0%
    8
    5%
    Region of Enrollment (Count of Participants)
    United Kingdom
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.3%
    1
    6.7%
    1
    25%
    3
    1.9%
    Moldova
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    13
    43.3%
    3
    20%
    0
    0%
    16
    9.9%
    Mauritius
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    6.7%
    6
    40%
    0
    0%
    8
    5%
    New Zealand
    20
    100%
    25
    100%
    20
    100%
    20
    100%
    8
    100%
    5
    100%
    14
    100%
    14
    46.7%
    5
    33.3%
    3
    75%
    134
    83.2%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment Emergent Adverse Event (TEAE)
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Count of Participants [Participants]
    17
    85%
    19
    76%
    14
    70%
    13
    65%
    7
    87.5%
    4
    80%
    13
    92.9%
    17
    56.7%
    10
    66.7%
    4
    100%
    2. Primary Outcome
    Title Body Weight at End of Treatment
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 19 25 20 20 8 5 14 30 15 4
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 19 25 20 20 8 5 14 30 15 4
    Mean (Standard Deviation) [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
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    sBP: Abnormally low
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3.3
    11%
    0
    0%
    0
    0%
    sBP: Grade 1 or mild
    20.0
    100%
    32.0
    128%
    35.0
    175%
    25.0
    125%
    37.5
    468.8%
    60.0
    1200%
    57.1
    407.9%
    26.7
    89%
    46.7
    311.3%
    25.0
    625%
    sBP: Grade 2 or moderate
    10.0
    50%
    8.0
    32%
    0
    0%
    5.0
    25%
    37.5
    468.8%
    0
    0%
    7.1
    50.7%
    20.0
    66.7%
    13.3
    88.7%
    50.0
    1250%
    sBP: Grade 3 or severe
    0
    0%
    4.0
    16%
    5.0
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3.3
    11%
    13.3
    88.7%
    0
    0%
    dBP: Abnormally low
    0
    0%
    4.0
    16%
    0
    0%
    0
    0%
    12.5
    156.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    dBP: Grade 1 or mild
    5.0
    25%
    20.0
    80%
    35.0
    175%
    20.0
    100%
    0
    0%
    60.0
    1200%
    21.4
    152.9%
    10.0
    33.3%
    26.7
    178%
    0
    0%
    dBP: Grade 2 or moderate
    5.0
    25%
    12.0
    48%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    14.3
    102.1%
    13.3
    44.3%
    6.7
    44.7%
    25.0
    625%
    dBP: Grade 3 or severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    25.0
    312.5%
    0
    0%
    7.1
    50.7%
    3.3
    11%
    6.7
    44.7%
    0
    0%
    Heart Rate: Abnormally low
    35.0
    175%
    32.0
    128%
    35.0
    175%
    30.0
    150%
    50.0
    625%
    20.0
    400%
    21.4
    152.9%
    13.3
    44.3%
    13.3
    88.7%
    0
    0%
    Heart Rate: Abnormally high
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    12.5
    156.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5. Primary Outcome
    Title Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Decline of > 10%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    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
    0%
    4.0
    16%
    10.0
    50%
    10.0
    50%
    12.5
    156.3%
    0.0
    0%
    21.4
    152.9%
    3.3
    11%
    6.7
    44.7%
    0.0
    0%
    Decline of >0-<=5%
    65.0
    325%
    48.0
    192%
    60.0
    300%
    50.0
    250%
    50.0
    625%
    20.0
    400%
    64.3
    459.3%
    80.0
    266.7%
    46.7
    311.3%
    50.0
    1250%
    6. Primary Outcome
    Title Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Hemoglobin: Grade 1
    5.0
    25%
    0.0
    0%
    0.0
    0%
    5.0
    25%
    0.0
    0%
    0.0
    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
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    0.0
    0%
    0.0
    0%
    Lymphocytes: Grade 2
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    10.0
    33.3%
    0.0
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    10.0
    33.3%
    0.0
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Platelets: Grade 1
    5.0
    25%
    0.0
    0%
    5.0
    25%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    6.7
    22.3%
    13.3
    88.7%
    25.0
    625%
    Platelets: Grade 2
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    16.7
    55.7%
    0.0
    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
    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
    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
    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
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Calcium: Grade 1
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    23.6%
    13.3
    44.3%
    0.0
    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
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Phosphate: Grade 2
    10.0
    50%
    20.0
    80%
    25.0
    125%
    15.0
    75%
    12.5
    156.3%
    0.0
    0%
    14.3
    102.1%
    13.3
    44.3%
    6.7
    44.7%
    0.0
    0%
    Phosphate: Grade 3
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    21.4
    152.9%
    3.3
    11%
    0.0
    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
    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%
    0.0
    0%
    0.0
    0%
    21.4
    152.9%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    Potassium: Grade 1
    0.0
    0%
    4.0
    16%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    0.0
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Sodium: Grade 1
    0.0
    0%
    8.0
    32%
    5.0
    25%
    0.0
    0%
    12.5
    156.3%
    20.0
    400%
    0.0
    0%
    3.3
    11%
    20.0
    133.3%
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Bicarbonate: Grade 1
    0.0
    0%
    16.0
    64%
    15.0
    75%
    5.0
    25%
    12.5
    156.3%
    20.0
    400%
    7.1
    50.7%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Bicarbonate: Grade 2
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    0.0
    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
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    0.0
    0%
    0.0
    0%
    Alanine aminotransferase: Grade 3+4
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    0.0
    0%
    0.0
    0%
    Alkaline phosphatase: Grade 1
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    0.0
    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
    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
    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
    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
    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%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    25.0
    625%
    Aspartate aminotransferase: Grade: 2
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    Aspartate aminotransferase: Grade: 3
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    44.7%
    0.0
    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
    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%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    44.7%
    0.0
    0%
    Bilirubin: Grade 1
    0.0
    0%
    0.0
    0%
    10.0
    50%
    10.0
    50%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    Bilirubin: Grade 2
    5.0
    25%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    0%
    25.0
    625%
    Bilirubin: Grade 3
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    6.7
    44.7%
    0.0
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    6.7
    44.7%
    0.0
    0%
    Glucose: Grade 1
    15.0
    75%
    4.0
    16%
    10.0
    50%
    5.0
    25%
    25.0
    312.5%
    0.0
    0%
    35.7
    255%
    10.0
    33.3%
    13.3
    88.7%
    0.0
    0%
    Glucose: Grade 2
    0.0
    0%
    4.0
    16%
    5.0
    25%
    0.0
    0%
    12.5
    156.3%
    0.0
    0%
    14.3
    102.1%
    13.3
    44.3%
    13.3
    88.7%
    25.0
    625%
    Glucose: Grade 3
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    Cholesterol: Grade 1
    20.0
    100%
    24.0
    96%
    30.0
    150%
    35.0
    175%
    12.5
    156.3%
    0.0
    0%
    42.9
    306.4%
    3.3
    11%
    20.0
    133.3%
    50.0
    1250%
    Cholesterol: Grade 2
    15.0
    75%
    8.0
    32%
    5.0
    25%
    5.0
    25%
    37.5
    468.8%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    6.7
    44.7%
    0.0
    0%
    Cholesterol: Grade 3
    0.0
    0%
    0.0
    0%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Cholesterol: Grade 3+4
    0.0
    0%
    0.0
    0%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    Triglycerides: Grade 1
    5.0
    25%
    16.0
    64%
    10.0
    50%
    15.0
    75%
    50.0
    625%
    20.0
    400%
    28.6
    204.3%
    16.7
    55.7%
    33.3
    222%
    25.0
    625%
    Triglycerides: Grade 2
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    14.3
    102.1%
    0.0
    0%
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Urate: Grade 1
    5.0
    25%
    12.0
    48%
    5.0
    25%
    0.0
    0%
    12.5
    156.3%
    0.0
    0%
    28.6
    204.3%
    10.0
    33.3%
    26.7
    178%
    0.0
    0%
    Urate: Grade 2
    0.0
    0%
    4.0
    16%
    0.0
    0%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Triacylglycerol lipase: Grade 1
    5.0
    25%
    12.0
    48%
    5.0
    25%
    0.0
    0%
    12.5
    156.3%
    20.0
    400%
    7.1
    50.7%
    13.3
    44.3%
    0.0
    0%
    0.0
    0%
    Triacylglycerol lipase: Grade 2
    15.0
    75%
    4.0
    16%
    10.0
    50%
    0.0
    0%
    12.5
    156.3%
    0.0
    0%
    7.1
    50.7%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    Triacylglycerol lipase: Grade 3
    5.0
    25%
    8.0
    32%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Triacylglycerol lipase: Grade 4
    0.0
    0%
    0.0
    0%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Triacylglycerol lipase: Grade 3+4
    5.0
    25%
    8.0
    32%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Creatinine: Grade 2
    0.0
    0%
    0.0
    0%
    0.0
    0%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Creatinine: Grade 3
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    12.5
    156.3%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Creatinine: Grade 3+4
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    12.5
    156.3%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    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
    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%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    20.0
    133.3%
    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
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Albumin: Grade 1
    5.0
    25%
    4.0
    16%
    0.0
    0%
    0.0
    0%
    25.0
    312.5%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Albumin: Grade 2
    0.0
    0%
    8.0
    32%
    0.0
    0%
    0.0
    0%
    0.0
    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
    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
    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
    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%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    0.0
    0%
    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%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    44.7%
    0.0
    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
    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
    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
    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)
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Prothrombin INR: Grade 1
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    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
    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
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Prothrombin INR: Grade 4
    0.0
    0%
    4.0
    16%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Prothrombin INR: Grade 3+4
    0.0
    0%
    4.0
    16%
    0.0
    0%
    0.0
    0%
    0.0
    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)
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Protein: Grade 1
    0.0
    0%
    4.0
    16%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    3.3
    11%
    26.7
    178%
    50.0
    1250%
    Protein: Grade 2
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    13.3
    88.7%
    0.0
    0%
    Protein: Grade 3
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    0%
    25.0
    625%
    Protein: Grade 4
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Protein: Grade 3+4
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    3.3
    11%
    0.0
    0%
    25.0
    625%
    10. Primary Outcome
    Title Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    QTcF: Abnormal
    5.0
    25%
    0.0
    0%
    5.0
    25%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    QTcB: Abnormal
    5.0
    25%
    8.0
    32%
    10.0
    50%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    28.6
    204.3%
    3.3
    11%
    6.7
    44.7%
    0.0
    0%
    Heart rate: Abnormal low
    25.0
    125%
    16.0
    64%
    10.0
    50%
    15.0
    75%
    25.0
    312.5%
    20.0
    400%
    14.3
    102.1%
    13.3
    44.3%
    0.0
    0%
    25.0
    625%
    Heart rate: Abnormal high
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    12.5
    156.3%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    QRS: Abnormal high
    0.0
    0%
    4.0
    16%
    0.0
    0%
    0.0
    0%
    0.0
    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%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    3.3
    11%
    0.0
    0%
    0.0
    0%
    PR: Abnormally high (200 ms<PR<= 240 ms)
    5.0
    25%
    8.0
    32%
    15.0
    75%
    10.0
    50%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    6.7
    22.3%
    13.3
    88.7%
    0.0
    0%
    PR: Abnormal high (240 ms<PR<=300 ms)
    10.0
    50%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    7.1
    50.7%
    0.0
    0%
    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
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    4 weeks after end of treatment
    100
    500%
    96.0
    384%
    100
    500%
    100
    500%
    87.5
    1093.8%
    0
    0%
    71.4
    510%
    100
    333.3%
    93.3
    622%
    100
    2500%
    12 weeks after end of treatment
    100
    500%
    84.0
    336%
    100
    500%
    100
    500%
    87.5
    1093.8%
    0
    0%
    71.4
    510%
    96.7
    322.3%
    93.3
    622%
    100
    2500%
    24 weeks after end of treatment
    100
    500%
    84.0
    336%
    100
    500%
    100
    500%
    87.5
    1093.8%
    0
    0%
    71.4
    510%
    96.7
    322.3%
    93.3
    622%
    100
    2500%
    12. Secondary Outcome
    Title Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    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)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    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)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    ALS-022399
    4.640
    (4.018)
    4.570
    (2.899)
    4.400
    (2.560)
    ALS-022227
    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)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    AL-335
    2.000
    2.000
    1.500
    1.000
    2.000
    ALS-022399
    3.0
    3.000
    3.000
    2.000
    3.000
    ALS-022227
    4.000
    4.000
    3.500
    3.500
    4.000
    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)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    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)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    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)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    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)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    AL-335
    6.000
    6.000
    6.000
    6.025
    8.670
    ALS-022399
    12.000
    12.000
    12.000
    12.000
    12.000
    ALS-022227
    24.00
    24.00
    24.00
    24.00
    23.90
    20. Secondary Outcome
    Title Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Median (Full Range) [Hours]
    6.000
    6.000
    6.000
    6.000
    25. Secondary Outcome
    Title AUC (0-last) of Simeprevir
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Mean (Standard Deviation) [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
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Median (Full Range) [Hours]
    24.00
    24.00
    24.00
    23.90
    29. Secondary Outcome
    Title Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Median (Full Range) [Hours]
    6.000
    6.000
    6.000
    4.500
    6.000
    34. Secondary Outcome
    Title AUC (0-last) of Odalasvir
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Median (Full Range) [Hours]
    24.00
    47.60
    47.50
    47.80
    47.50
    38. Secondary Outcome
    Title Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 11 11 16 6 27
    Mean (Standard Deviation) [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
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Number [Percentage of participants]
    0
    0%
    16.0
    64%
    0
    0%
    0
    0%
    0
    0%
    100.0
    2000%
    14.3
    102.1%
    3.3
    11%
    0
    0%
    0
    0%
    40. Secondary Outcome
    Title Percentage of Participants With On-treatment Failure
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Number [Percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    12.5
    156.3%
    0
    0%
    7.1
    50.7%
    0
    0%
    0
    0%
    0
    0%
    41. Secondary Outcome
    Title Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Day 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 3
    0
    0%
    0
    0%
    0
    0%
    5.0
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6.7
    44.7%
    0
    0%
    Week 1
    5.0
    25%
    20.0
    80%
    0
    0%
    30.0
    150%
    12.5
    156.3%
    20.0
    400%
    35.7
    255%
    16.7
    55.7%
    13.3
    88.7%
    25.0
    625%
    Week 2
    35.0
    175%
    44.0
    176%
    45.0
    225%
    70.0
    350%
    25.0
    312.5%
    40.0
    800%
    64.3
    459.3%
    50.0
    166.7%
    66.7
    444.7%
    75.0
    1875%
    Week 3
    70.0
    350%
    76.0
    304%
    75.0
    375%
    80.0
    400%
    62.5
    781.3%
    60.0
    1200%
    85.7
    612.1%
    73.3
    244.3%
    86.7
    578%
    100
    2500%
    Week 4
    80.0
    400%
    92.0
    368%
    90.0
    450%
    85.0
    425%
    87.5
    1093.8%
    60.0
    1200%
    92.9
    663.6%
    80.0
    266.7%
    86.7
    578%
    100
    2500%
    Week 5
    100
    500%
    96.0
    384%
    100
    500%
    90.0
    450%
    100
    1250%
    80.0
    1600%
    92.9
    663.6%
    90.0
    300%
    100
    666.7%
    100
    2500%
    Week 6
    90.0
    450%
    100
    400%
    85.0
    425%
    90.0
    450%
    100
    1250%
    100
    2000%
    92.9
    663.6%
    96.7
    322.3%
    100
    666.7%
    100
    2500%
    Week 7
    90.0
    450%
    96.0
    384%
    95.0
    475%
    NA
    NaN
    100
    1250%
    80.0
    1600%
    85.7
    612.1%
    100
    333.3%
    100
    666.7%
    100
    2500%
    Week 8
    95.0
    475%
    100
    400%
    100
    500%
    NA
    NaN
    87.5
    1093.8%
    100
    2000%
    85.7
    612.1%
    100
    333.3%
    93.3
    622%
    100
    2500%
    Week 9
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    92.9
    663.6%
    NA
    NaN
    93.3
    622%
    100
    2500%
    Week 10
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    92.9
    663.6%
    NA
    NaN
    93.3
    622%
    100
    2500%
    Week 11
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    92.9
    663.6%
    NA
    NaN
    86.7
    578%
    100
    2500%
    Week 12
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    85.7
    612.1%
    NA
    NaN
    93.3
    622%
    100
    2500%
    End of treatment
    95.0
    475%
    100
    400%
    100
    500%
    90.0
    450%
    87.5
    1093.8%
    100
    2000%
    85.7
    612.1%
    100
    333.3%
    93.3
    622%
    100
    2500%
    42. Secondary Outcome
    Title Percentage of Participants Who Achieved HCV RNA <LLOQ
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 20 25 20 20 8 5 14 30 15 4
    Day 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 1
    0
    0%
    8.0
    32%
    0
    0%
    10.0
    50%
    0
    0%
    0
    0%
    14.3
    102.1%
    16.7
    55.7%
    13.3
    88.7%
    25.0
    625%
    Week 2
    20.0
    100%
    20.0
    80%
    15.0
    75%
    40.0
    200%
    0
    0%
    20.0
    400%
    42.9
    306.4%
    50.0
    166.7%
    66.7
    444.7%
    75.0
    1875%
    Week 3
    40.0
    200%
    40.0
    160%
    45.0
    225%
    65.0
    325%
    37.5
    468.8%
    60.0
    1200%
    50.0
    357.1%
    73.3
    244.3%
    86.7
    578%
    100
    2500%
    Week 4
    55.0
    275%
    52.0
    208%
    60.0
    300%
    80.0
    400%
    62.5
    781.3%
    40.0
    800%
    78.6
    561.4%
    80.0
    266.7%
    86.7
    578%
    100
    2500%
    Week 5
    75.0
    375%
    96.0
    384%
    85.0
    425%
    85.0
    425%
    75.0
    937.5%
    80.0
    1600%
    85.7
    612.1%
    90.0
    300%
    100
    666.7%
    100
    2500%
    Week 6
    80.0
    400%
    88.0
    352%
    85.0
    425%
    80.0
    400%
    87.5
    1093.8%
    80.0
    1600%
    92.9
    663.6%
    96.7
    322.3%
    100
    666.7%
    100
    2500%
    Week 7
    80.0
    400%
    92.0
    368%
    95.0
    475%
    NA
    NaN
    87.5
    1093.8%
    80.0
    1600%
    85.7
    612.1%
    100
    333.3%
    100
    666.7%
    100
    2500%
    Week 8
    85.0
    425%
    96.0
    384%
    100
    500%
    NA
    NaN
    87.5
    1093.8%
    100
    2000%
    85.7
    612.1%
    100
    333.3%
    93.3
    622%
    100
    2500%
    Week 9
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    92.9
    663.6%
    NA
    NaN
    93.3
    622%
    100
    2500%
    Week 10
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    92.9
    663.6%
    NA
    NaN
    93.3
    622%
    100
    2500%
    Week 11
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    92.9
    663.6%
    NA
    NaN
    86.7
    578%
    100
    2500%
    Week 12
    NA
    NaN
    NA
    NaN
    NA
    NaN
    NA
    NaN
    87.5
    1093.8%
    NA
    NaN
    78.6
    561.4%
    NA
    NaN
    93.3
    622%
    100
    2500%
    End of treatment
    85.0
    425%
    96.0
    384%
    100
    500%
    80.0
    400%
    87.5
    1093.8%
    100
    2000%
    78.6
    561.4%
    100
    333.3%
    93.3
    622%
    100
    2500%
    43. Secondary Outcome
    Title Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA
    Description Time to achieve undetectable HCV RNA or < LLOQ HCV RNA was reported.
    Time Frame Up to Week 24 (follow up visit)

    Outcome Measure Data

    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)
    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.
    Measure Participants 0 0 0 0 0 0 0 0 0 0
    44. Secondary Outcome
    Title Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
    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)

    Outcome Measure Data

    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)
    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.
    Measure Participants 0 4 0 0 1 5 3 1 0 0
    Count of Participants [Participants]
    4
    20%
    1
    4%
    0
    0%
    2
    10%
    1
    12.5%

    Adverse Events

    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)
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/20 (5%) 2/25 (8%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 2/15 (13.3%) 1/4 (25%)
    Cardiac disorders
    Atrioventricular Block Second Degree 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    General disorders
    Pain 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Infections and infestations
    Cellulitis 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Pneumonia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Injury, poisoning and procedural complications
    Fall 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Investigations
    Alanine Aminotransferase Increased 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Aspartate Aminotransferase Increased 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional Cell Carcinoma Urethra 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Other (Not Including 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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/20 (85%) 20/25 (80%) 14/20 (70%) 14/20 (70%) 7/8 (87.5%) 4/5 (80%) 13/14 (92.9%) 18/30 (60%) 10/15 (66.7%) 4/4 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Lymphadenopathy 1/20 (5%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Cardiac disorders
    Atrioventricular Block First Degree 1/20 (5%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Palpitations 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Supraventricular Tachycardia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Congenital, familial and genetic disorders
    Porphyria Non-Acute 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Ear and labyrinth disorders
    Ear Discomfort 1/20 (5%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Ear Pruritus 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Eye disorders
    Dry Eye 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Erythema of Eyelid 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Eye Irritation 0/20 (0%) 0/25 (0%) 2/20 (10%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Eye Pruritus 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 1/5 (20%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Vision Blurred 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Visual Impairment 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Gastrointestinal disorders
    Abdominal Discomfort 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Abdominal Distension 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Abdominal Pain 3/20 (15%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 1/14 (7.1%) 1/30 (3.3%) 0/15 (0%) 1/4 (25%)
    Abdominal Pain Lower 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Abdominal Pain Upper 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Constipation 1/20 (5%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Dental Caries 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Diarrhoea 1/20 (5%) 2/25 (8%) 1/20 (5%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 1/14 (7.1%) 3/30 (10%) 1/15 (6.7%) 0/4 (0%)
    Dry Mouth 1/20 (5%) 1/25 (4%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Dyspepsia 0/20 (0%) 1/25 (4%) 1/20 (5%) 0/20 (0%) 2/8 (25%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Eructation 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Gastrooesophageal Reflux Disease 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Loose Tooth 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Nausea 2/20 (10%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 3/30 (10%) 0/15 (0%) 0/4 (0%)
    Noninfective Sialoadenitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Salivary Gland Calculus 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Toothache 0/20 (0%) 1/25 (4%) 0/20 (0%) 1/20 (5%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Vomiting 1/20 (5%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 1/15 (6.7%) 1/4 (25%)
    General disorders
    Chest Discomfort 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Chest Pain 1/20 (5%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Fatigue 6/20 (30%) 4/25 (16%) 2/20 (10%) 3/20 (15%) 2/8 (25%) 0/5 (0%) 6/14 (42.9%) 3/30 (10%) 1/15 (6.7%) 2/4 (50%)
    Feeling Abnormal 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Pain 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Peripheral Swelling 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Pyrexia 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Swelling 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Vessel Puncture Site Bruise 0/20 (0%) 1/25 (4%) 1/20 (5%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 2/30 (6.7%) 0/15 (0%) 0/4 (0%)
    Vessel Puncture Site Haematoma 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Vessel Puncture Site Phlebitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Infections and infestations
    Angular Cheilitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Bronchitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 1/4 (25%)
    Conjunctivitis 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Conjunctivitis Viral 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Folliculitis 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Furuncle 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Gastroenteritis 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Gingivitis 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Hordeolum 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Influenza 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Laryngitis 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Lower Respiratory Tract Infection 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 1/5 (20%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 2/4 (50%)
    Pharyngitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Pneumonia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Rash Pustular 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Respiratory Tract Infection 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Respiratory Tract Infection Viral 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Rhinitis 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Skin Infection 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Tonsillitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Tooth Abscess 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Tooth Infection 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Upper Respiratory Tract Infection 6/20 (30%) 3/25 (12%) 1/20 (5%) 1/20 (5%) 3/8 (37.5%) 2/5 (40%) 4/14 (28.6%) 3/30 (10%) 0/15 (0%) 1/4 (25%)
    Urinary Tract Infection 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 2/30 (6.7%) 0/15 (0%) 0/4 (0%)
    Viral Infection 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Wound Infection 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Injury, poisoning and procedural complications
    Accidental Overdose 1/20 (5%) 1/25 (4%) 1/20 (5%) 3/20 (15%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Chest Injury 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Contusion 2/20 (10%) 2/25 (8%) 1/20 (5%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 4/30 (13.3%) 0/15 (0%) 0/4 (0%)
    Epicondylitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Eye Contusion 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Joint Injury 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Laceration 0/20 (0%) 1/25 (4%) 0/20 (0%) 2/20 (10%) 0/8 (0%) 1/5 (20%) 1/14 (7.1%) 2/30 (6.7%) 0/15 (0%) 0/4 (0%)
    Ligament Sprain 0/20 (0%) 1/25 (4%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Limb Injury 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Lip Injury 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Muscle Strain 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Scratch 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Skin Abrasion 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 1/15 (6.7%) 0/4 (0%)
    Sunburn 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Thermal Burn 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Tooth Fracture 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Wound 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Investigations
    Blood Creatine Phosphokinase Increase 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 2/30 (6.7%) 1/15 (6.7%) 0/4 (0%)
    Blood Pressure Increased 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 1/4 (25%)
    Ejection Fraction Decreased 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Electrocardiogram Pr Prolongation 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Lipase Increased 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Metabolism and nutrition disorders
    Appetite Disorder 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Decreased Appetite 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Hyperphagia 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Increased Appetite 0/20 (0%) 1/25 (4%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 1/5 (20%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 1/4 (25%)
    Back Pain 1/20 (5%) 1/25 (4%) 2/20 (10%) 1/20 (5%) 1/8 (12.5%) 0/5 (0%) 3/14 (21.4%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Bursitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Joint Stiffness 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 1/15 (6.7%) 0/4 (0%)
    Muscle Tightness 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Musculoskeletal Chest Pain 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Musculoskeletal Pain 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Musculoskeletal Stiffness 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 1/5 (20%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Myalgia 1/20 (5%) 1/25 (4%) 1/20 (5%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 1/15 (6.7%) 0/4 (0%)
    Neck Pain 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 1/5 (20%) 1/14 (7.1%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Pain in Extremity 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Rotator Cuff Syndrome 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Nervous system disorders
    Burning Sensation 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Disturbance in Attention 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Dizziness 1/20 (5%) 1/25 (4%) 0/20 (0%) 1/20 (5%) 1/8 (12.5%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Dysgeusia 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Headache 8/20 (40%) 5/25 (20%) 2/20 (10%) 3/20 (15%) 4/8 (50%) 2/5 (40%) 3/14 (21.4%) 2/30 (6.7%) 2/15 (13.3%) 1/4 (25%)
    Hypogeusia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Hyposmia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Lethargy 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 2/8 (25%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Memory Impairment 1/20 (5%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Migraine 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Paraesthesia 0/20 (0%) 1/25 (4%) 0/20 (0%) 1/20 (5%) 1/8 (12.5%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Presyncope 0/20 (0%) 1/25 (4%) 1/20 (5%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Sensory Disturbance 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Tension Headache 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Psychiatric disorders
    Abnormal Dreams 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Anxiety 2/20 (10%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Depressed Mood 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Dysphoria 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Flat Affect 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Insomnia 1/20 (5%) 1/25 (4%) 3/20 (15%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Irritability 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Libido Decreased 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Nightmare 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Panic Attack 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Sleep Disorder 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 2/30 (6.7%) 0/15 (0%) 0/4 (0%)
    Renal and urinary disorders
    Micturition Urgency 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Polyuria 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Renal Colic 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Reproductive system and breast disorders
    Vaginal Discharge 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Cough 1/20 (5%) 2/25 (8%) 1/20 (5%) 2/20 (10%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 2/30 (6.7%) 0/15 (0%) 0/4 (0%)
    Dry Throat 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Dysphonia 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Dyspnoea 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Epistaxis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Nasal Congestion 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 2/8 (25%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Oropharyngeal Pain 1/20 (5%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 1/8 (12.5%) 1/5 (20%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Rhinorrhoea 2/20 (10%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Sinus Congestion 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Sneezing 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Throat Irritation 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Upper-Airway Cough Syndrome 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Skin and subcutaneous tissue disorders
    Acne 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Dermal Cyst 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Dermatitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Dermatitis Atopic 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Dermatitis Contact 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Eczema 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Erythema 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Hand Dermatitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Hyperhidrosis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Mechanical Urticaria 0/20 (0%) 1/25 (4%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Night Sweats 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Photosensitivity Reaction 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Pruritus 1/20 (5%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 1/4 (25%)
    Rash 0/20 (0%) 0/25 (0%) 1/20 (5%) 0/20 (0%) 1/8 (12.5%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Rash Papular 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Rash Pruritic 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Seborrhoeic Dermatitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Skin Fissures 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 1/14 (7.1%) 0/30 (0%) 0/15 (0%) 0/4 (0%)
    Vascular disorders
    Aortic Aneurysm 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Haematoma 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Hot Flush 0/20 (0%) 0/25 (0%) 0/20 (0%) 1/20 (5%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 1/30 (3.3%) 0/15 (0%) 0/4 (0%)
    Hypertension 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 1/15 (6.7%) 0/4 (0%)
    Phlebitis 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/20 (0%) 0/8 (0%) 0/5 (0%) 0/14 (0%) 0/30 (0%) 0/15 (0%) 1/4 (25%)

    Limitations/Caveats

    Limitations of the study included the open-label design, limited sample size, and the lack of a comparator group.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.

    Results Point of Contact

    Name/Title Director
    Organization Alios BioPharma, Inc
    Phone 844-434-4210
    Email ClinicalTrialDisclosure@its.jnj.com
    Responsible Party:
    Alios Biopharma Inc.
    ClinicalTrials.gov Identifier:
    NCT02569710
    Other Study ID Numbers:
    • AL-335-604
    First Posted:
    Oct 7, 2015
    Last Update Posted:
    Jul 16, 2019
    Last Verified:
    Jun 1, 2019