NCT02185794

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection

Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	Voxilaprevir	Voxilaprevir tablets administered orally once daily
DRUG	Placebo to match voxilaprevir	Placebo to match voxilaprevir tablets administered orally once daily
DRUG	SOF/VEL	400 mg/100 mg FDC tablet administered orally once daily

Timeline

• Start date: 2014-06-13
• Primary completion: 2014-12-22
• Completion: 2015-09-28
• First posted: 2014-07-10
• Last updated: 2020-09-17
• Results posted: 2020-08-21

Locations

11 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study