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Clinical Trials/NCT02654236
NCT02654236CompletedNot Applicable

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

Suthat Liangpunsakul1 site in 1 country30 target enrollmentStarted: April 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Placebo

Placebo Comparator

Heavy Drinkers on placebo

Intervention: Placebo (Drug)

10 mg Obeticholic Acid (OCA)

Experimental

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

Intervention: 10 mg Obeticholic Acid (OCA) (Drug)

Outcomes

Primary Outcomes

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

Time Frame: Baseline to 28 days

Change in FGF19 Levels to Determine Effect of FXR

Time Frame: Baseline to 28 days

Secondary Outcomes

  • Change in Fasting Serum Bile Salt Levels(Baseline to 28 days)
  • Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance(Baseline to 28 days)
  • Change in Activation of Innate Immunity Through Measures of IL-6(Baseline to 28 days)
  • Change in Intestinal Inflammation by Measuring Stool Calprotectin(Baseline to 28 days)
  • Change in Activation of Innate Immunity Through Measures of IL-8(Baseline to 28 days)
  • Change in Activation of Innate Immunity Through Measures of IL-1(Baseline to 28 days)
  • Change in Oxidative Stress Level by Measuring Malondialdehyde(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)
  • Change in Bacterial Translocation Through Measures of Serum sCD14(Baseline to 28 days)
  • Change in Activation of Innate Immunity Through Measures of TNF-alpha(Baseline to 28 days)

Investigators

Sponsor
Suthat Liangpunsakul
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Suthat Liangpunsakul

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

Indiana University School of Medicine

Study Sites (1)

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