Trials / Completed
CompletedNCT02959138
Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of GS-9876 in Subjects With Impaired Renal Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of lanraplenib in participants with impaired renal function relative to matched healthy controls. Participants in this study will be enrolled using an adaptive design that includes up to 3 enrolled cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled in adaptive Cohorts 2 and/or 3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lanraplenib. | 20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1 |
Timeline
- Start date
- 2016-11-21
- Primary completion
- 2018-10-05
- Completion
- 2018-10-05
- First posted
- 2016-11-08
- Last updated
- 2019-10-25
- Results posted
- 2019-10-25
Locations
6 sites across 3 countries: United States, Germany, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02959138. Inclusion in this directory is not an endorsement.