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The Effect of Obeticholic Acid in Healthy Volunteers

NCT05740631 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-23

No results posted yet for this study

Summary

This study investigates whether obeticholic acid affects gut microbiota, gastric motility, accommodation, and gastrointestinal peptide in healthy subjects.

This study is a single-blind, placebo-controlled, randomized study. Twelve healthy volunteers will take one tablet containing obeticholic acid (10 mg) or a placebo once per day for 21 days for the first intervention. After 28 days washout period, they will take a tablet different from the one taken in the first intervention.

Before the first intervention, they will receive MMC, IGP and endoscopy exam. At the end of the first and second interventions, they will receive the same exams. During MMC\&IGP, we will take blood samples to measure plasma hormones (motilin, octa-ghrelin, GLP-1, GLP-2, GIP, and insulin) and take duodenal fluid. When the endoscopy, we will take samples from the duodenal for microbiota, permeability measurement, RNA, protein, and pathology.

Before and during the interventions, stool samples will be collected.

Conditions

  • Healthy

Interventions

DRUG

Ocaliva

Assignment of treatment obeticholic acid will be started (randomized) after the study visit and administered orally in a single-blind fashion for 21 days.

DRUG

Placebo

Assignment of treatment placebo will be started (randomized) after the study visit and placebo will be administered orally in a single-blind fashion for 21 days.

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2023-07-22
Completion
2023-07-22

Countries

  • Belgium

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 NCT05740631 on ClinicalTrials.gov