At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
Voxilaprevirdrug
Likely dose
Voxilaprevir 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Voxilaprevir for HCV Infection. Completed, enrolled 33 participants across 4 sites in 3 countries.
Detailed 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%).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHCV Infection
CountriesGermany, New Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMar 2015
Primary CompletionMar 2016
TodayJul 2026
First PostedMar 25, 2015
Enrollment StartMar 24, 2015
Primary CompletionMar 4, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.3 years ago
Interventions
Voxilaprevirdrug
100 mg tablet administered orally