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NCT01914562 · ClinicalTrials.gov registry record · Phase 1
Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)
A Phase 1 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01914562 is a Phase 1 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 32 participants.
The verdict
NCT01914562, a Phase 1 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG OCA 10 mg
- DRUG OCA 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-08 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01914562
The ClinicalTrials.gov registry entry for NCT01914562 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intercept Pharmaceuticals, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which OCA 10 mg is the first listed.
NCT01914562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01914562 about?
NCT01914562 is a clinical study titled "Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)". 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.
What is the current status of trial NCT01914562?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-08. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01914562?
The interventions under investigation include: OCA 10 mg (DRUG), OCA 25 mg (DRUG).
Who is sponsoring clinical trial NCT01914562?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
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