Trials / Completed
CompletedNCT02441829
Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function
A Phase 1 Open-Label, Parallel-Group, Adaptive, Single Dose Study to Evaluate the Pharmacokinetics of GS-6615 in Subjects With Normal and Impaired Renal Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired renal function. Participants in the healthy control group will be matched to participants with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eleclazine | Eleclazine tablets administered orally in morning with food |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2015-05-12
- Last updated
- 2015-12-22
Locations
7 sites across 3 countries: United States, Moldova, Romania
Source: ClinicalTrials.gov record NCT02441829. Inclusion in this directory is not an endorsement.