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Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

NCT02654236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-25

Study results available
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Summary

The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.

Conditions

  • Alcohol Consumption

Interventions

DRUG

Placebo

1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.

DRUG

10 mg Obeticholic Acid (OCA)

10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Intercept Pharmaceuticals

    collaborator INDUSTRY

  • Suthat Liangpunsakul

    lead OTHER

Principal Investigators

  • Suthat Liangpunsakul, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654236 on ClinicalTrials.gov