NCT02654236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

April 25, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

3.4 years

First QC Date

January 6, 2016

Results QC Date

March 6, 2023

Last Update Submit

April 3, 2023

Conditions

Alcohol Consumption

Outcome Measures

Primary Outcomes (2)

  • Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR

    Baseline to 28 days

  • Change in FGF19 Levels to Determine Effect of FXR

    Baseline to 28 days

Secondary Outcomes (11)

  • Change in Fasting Serum Bile Salt Levels

    Baseline to 28 days

  • Change in Oxidative Stress Level by Measuring Malondialdehyde

    Baseline to 28 days

  • Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance

    Baseline to 28 days

  • Change in Gut Permeability Through Lactulose/Mannitol Test

    Baseline to 28 days

  • Change in Bacterial Translocation Through Measures of Plasma LPS

    Baseline to 28 days

  • +6 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Heavy Drinkers on placebo

Drug: Placebo

10 mg Obeticholic Acid (OCA)

EXPERIMENTAL

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

Drug: 10 mg Obeticholic Acid (OCA)

Non-drinking Controls

NO INTERVENTION

Non-drinking healthy controls

Interventions

PlaceboDRUG

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

Placebo
10 mg Obeticholic Acid (OCA)DRUG

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

10 mg Obeticholic Acid (OCA)

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Results Point of Contact

Title
Dr. Suthat Liangpunsakul
Organization
IU School of Medicine
sliangpu@iu.edu
(317) 988-3232

Study Officials

  • Suthat Liangpunsakul, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Suthat Liangpunsakul, Associate Professor of Medicine, Biochemistry and Molecular Biology

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 13, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

April 25, 2023

Results First Posted

April 25, 2023

Record last verified: 2023-04

Locations

US(1)