Trials / Completed
CompletedNCT02002767
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Velpatasvir | Velpatasvir 100 mg (2 x 50 mg tablets) administered orally |
Timeline
- Start date
- 2013-12-16
- Primary completion
- 2014-06-09
- Completion
- 2014-06-09
- First posted
- 2013-12-06
- Last updated
- 2020-11-16
- Results posted
- 2020-11-16
Locations
5 sites across 2 countries: United States, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02002767. Inclusion in this directory is not an endorsement.