drugset / Trial / NCT05740631

The Effect of Obeticholic Acid in Healthy Volunteers

NCT05740631

RandomizedCrossoverSingle-blindOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Obeticholic Acid Small molecule 10 mg Oral

Indications

No indication recorded.