Trials / Completed
CompletedNCT01914562
Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)
An Open Label Trial to Assess the Effects of Food on the Pharmacokinetic Parameters of Obeticholic Acid (OCA)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Intercept Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is an open label, randomized, balanced, single center, single dose, trial to assess the pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence, crossover manner.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OCA 10 mg | OCA 10 mg tablet oral |
| DRUG | OCA 25 mg | OCA 25 mg tablet oral |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2013-08-02
- Last updated
- 2014-08-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01914562. Inclusion in this directory is not an endorsement.