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NCT01904539 · ClinicalTrials.gov registry record · Phase 1

Hepatic Impairment Trial of Obeticholic Acid

A Phase 1 study, sponsored by Intercept Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT01904539 is a Phase 1 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 32 participants.

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The verdict

NCT01904539, 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 a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.

Interventions

  • DRUG obeticholic acid 10 mg

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2013-06
Est. Completion 2013-10
Phase Phase 1

Sponsor

Intercept Pharmaceuticals

18 total trials

What the Registry Record Tells You About NCT01904539

The ClinicalTrials.gov registry entry for NCT01904539 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 1 intervention - of which obeticholic acid 10 mg is the first listed.

NCT01904539 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01904539 about?

NCT01904539 is a clinical study titled "Hepatic Impairment Trial of Obeticholic Acid". This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.

What is the current status of trial NCT01904539?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-06. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01904539?

The interventions under investigation include: obeticholic acid 10 mg (DRUG).

Who is sponsoring clinical trial NCT01904539?

This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.