Trials / Completed
CompletedNCT02412098
Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic 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 Hepatic Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral eleclazine and its metabolite, GS-623134, in participants with normal and impaired hepatic function. Participants in the healthy control group will be matched to participants with impaired hepatic function by age (± 5 years), gender, and body mass index (± 10%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eleclazine | Eleclazine tablets administered orally |
Timeline
- Start date
- 2015-03-19
- Primary completion
- 2016-04-22
- Completion
- 2016-04-22
- First posted
- 2015-04-08
- Last updated
- 2019-07-29
- Results posted
- 2019-07-29
Locations
7 sites across 4 countries: United States, Germany, New Zealand, Romania
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02412098. Inclusion in this directory is not an endorsement.