Trials / Completed
CompletedNCT01904539
Hepatic Impairment Trial of Obeticholic Acid
An Open-Label, Single-Dose Trial to Assess the Effects of Hepatic Impairment on the Pharmacokinetics of Obeticholic Acid (OCA)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Intercept Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | obeticholic acid 10 mg | Single dose OCA 10mg in each arm |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2013-07-22
- Last updated
- 2013-10-24
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01904539. Inclusion in this directory is not an endorsement.