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

NCT ID: NCT02654236

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Heavy Drinkers on placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

10 mg Obeticholic Acid (OCA)

10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks.

Group Type: EXPERIMENTAL

10 mg Obeticholic Acid (OCA)

Intervention Type: DRUG

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

Non-drinking Controls

Non-drinking healthy controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Placebo

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Individuals ≥ 21 to 65 years old
• Able to provide informed consent & negative urine pregnancy test where appropriate
• Healthy controls must have not consumed any alcohol within 3 months prior to the screening visit
• Heavy alcohol drinking is defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months
• Women of child bearing potential should be willing to practice contraception throughout the treatment period

Exclusion Criteria

• Active infection as evidenced by positive urine culture, blood culture, or pneumonia
• Serum creatinine > 1.5 mg/dL
• Known co-existing infection with hepatitis C, hepatitis B, or HIV
• Significant systemic or major illness including COPD, CHF and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study.
• Participation in another investigational drug, biologic, or medical device trial within 30 days prior to Screening
• Previous history of jaundice or signs of liver diseases such as spider angiomata, ascites, or history of esophageal varices or hepatic encephalopathy
• Total bilirubin > 2 mg/dl and INR > 1.5 Page 20 of 37
• Women who are pregnant or nursing
• Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
• Subjects who are taking warfarin

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Intercept Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Suthat Liangpunsakul

OTHER

Sponsor Role: lead

Responsible Party

Suthat Liangpunsakul

Suthat Liangpunsakul, Associate Professor of Medicine, Biochemistry and Molecular Biology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suthat Liangpunsakul, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TREAT 005

Identifier Type: -

Identifier Source: org_study_id