Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Status and phase
Completed
Phase 1
Conditions
Hepatitis C Virus Infection
Treatments
Drug: Placebo to match voxilaprevir
Drug: Voxilaprevir
Drug: SOF/VEL
Details and patient eligibility
About
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
Enrollment
101 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Chronic genotype 1-4 HCV infection
- For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria:
- Pregnant or nursing female or male with pregnant female partner
- Presence of cirrhosis
- Prior exposure to approved or experimental HCV Protease Inhibitors
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
101 participants in 16 patient groups, including a placebo group
Placebo (GT 1a, Cohort 1)
Placebo Comparator group
Description:
Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions.
Treatment:
Drug: Placebo to match voxilaprevir
Voxilaprevir 50 mg (GT 1a, Cohort 1)
Experimental group
Description:
Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 1a, Cohort 1)
Experimental group
Description:
Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 300 mg (GT 1a, Cohort 1)
Experimental group
Description:
Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Placebo (GT 3, Cohort 2)
Placebo Comparator group
Description:
Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Treatment:
Drug: Placebo to match voxilaprevir
Voxilaprevir 50 mg (GT 3, Cohort 2)
Experimental group
Description:
Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 3, Cohort 2)
Experimental group
Description:
Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 300 mg (GT 3, Cohort 2)
Experimental group
Description:
Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Placebo (GT 2, Cohort 3)
Placebo Comparator group
Description:
Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Treatment:
Drug: Placebo to match voxilaprevir
Voxilaprevir 100 mg (GT 2, Cohort 3)
Experimental group
Description:
Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 4, Cohort 4)
Experimental group
Description:
Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 1b, Cohort 5)
Experimental group
Description:
Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
Experimental group
Description:
Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 600 mg (Cohorts 7-9)
Experimental group
Description:
Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days.
Treatment:
Drug: Voxilaprevir
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)
Experimental group
Description:
Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal.
Treatment:
Drug: Voxilaprevir
Drug: SOF/VEL
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)
Experimental group
Description:
Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.
Treatment:
Drug: Voxilaprevir
Drug: SOF/VEL
Trial contacts and locations
11
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Data sourced from clinicaltrials.gov
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