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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.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2013-10
Est. Completion 2013-11
Phase Phase 1
Intercept Pharmaceuticals

18 total trials

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.

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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Source: ClinicalTrials.gov NCT01933503, the US trial registry maintained by the National Library of Medicine. NCT01933503 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.