NCT02397707

Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in the healthy control group will be matched to participants with impaired hepatic function by gender, age (± 10 years), and body mass index (± 15%).

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	Voxilaprevir	100 mg tablet administered orally

Timeline

• Start date: 2015-03-24
• Primary completion: 2016-03-04
• Completion: 2016-03-04
• First posted: 2015-03-25
• Last updated: 2020-04-09
• Results posted: 2020-03-20

Locations

4 sites across 3 countries: United States, Germany, New Zealand