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NCT01933503 · ClinicalTrials.gov registry record · Phase 1
Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA)
A Phase 1 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01933503: Completed Phase 1 study, sponsored by Intercept Pharmaceuticals.
NCT01933503 is a Phase 1 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01933503, a Phase 1 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a single center, open label, randomized, parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of obeticholic acid (OCA).
Primary Outcome
Maximum concentration (observed) following single and multiple doses of OCA 5 mg, 10 mg, and 25 mg
Interventions
- DRUG OCA 10 mg
- DRUG OCA 25 mg
- DRUG OCA 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01933503 record still lists
NCT01933503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which OCA 10 mg is the first listed.
NCT01933503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01933503 about?
NCT01933503 is a clinical study titled "Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA)". This is a single center, open label, randomized, parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of obeticholic acid (OCA).
What is the current status of trial NCT01933503?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01933503?
The interventions under investigation include: OCA 10 mg (DRUG), OCA 25 mg (DRUG), OCA 5 mg (DRUG).
Who is sponsoring clinical trial NCT01933503?
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 NCT01933503's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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