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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: Completed Phase 1 study, sponsored by Intercept Pharmaceuticals.
NCT01914562 is a Phase 1 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
maximum concentration (observed)
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 |
What the finished NCT01914562 record still lists
NCT01914562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which OCA 10 mg is the first listed.
NCT01914562 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01914562's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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