Trials / Completed
CompletedNCT02521376
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entospletinib | Entospletinib 100 mg tablet administered orally |
Timeline
- Start date
- 2015-11-16
- Primary completion
- 2017-10-25
- Completion
- 2017-10-25
- First posted
- 2015-08-13
- Last updated
- 2019-07-26
- Results posted
- 2019-07-26
Locations
6 sites across 3 countries: United States, Germany, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02521376. Inclusion in this directory is not an endorsement.