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

Suthat Liangpunsakul

Status

Completed

Conditions

Alcohol Consumption

Treatments

Drug: 10 mg Obeticholic Acid (OCA)

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT02654236

TREAT 005

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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