At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
Velpatasvirdrug
Likely dose
Velpatasvir 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-5816 in Subjects With Normal Renal Function and Severe Renal Impairment
In Brief
A Phase 1 clinical trial evaluating Velpatasvir for Hepatitis C Virus. Completed, enrolled 19 participants across 5 sites in 2 countries.
Detailed Summary
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
CountriesNew Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartDec 2013
Primary CompletionJun 2014
TodayJul 2026
First PostedDec 6, 2013
Enrollment StartDec 16, 2013
Primary CompletionJun 9, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.6 years ago
Interventions
Velpatasvirdrug
Velpatasvir 100 mg (2 x 50 mg tablets) administered orally