At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 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 Renal Function and Severe Renal Impairment
In Brief
A Phase 1 clinical trial evaluating Voxilaprevir for HCV Infection. Completed, enrolled 20 participants across 4 sites in 3 countries.
Detailed Summary
The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHCV Infection
CountriesGermany, New Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMay 2015
Primary CompletionSep 2015
TodayJul 2026
First PostedMar 30, 2015
Enrollment StartMay 5, 2015
Primary CompletionSep 28, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.3 years ago
Interventions
Voxilaprevirdrug
100 mg tablet administered orally