NCT05740631

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 22, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

September 16, 2022

Last Update Submit

February 13, 2023

Conditions

Healthy

Keywords

Obeticholic acidFarnesoid X receptorgastric accommodationgastrointestinal hormonesgut microbiota

Outcome Measures

Primary Outcomes (1)

  • Changes in appetite after administration of obeticholic acid compared to placebo

    Assessment by questionnaire(100mm Visual Analogue Scale) every 10 minutes.

    During MMCⅢ (300 min)

Secondary Outcomes (3)

  • Change in serum GI hormones concentrations

    During MMCⅢ (300 min)

  • Change in gastric motility

    During MMCⅢ (300 min)

  • Change in gut microbiota

    12 days

Study Arms (2)

Obeticholic acid

EXPERIMENTAL

FXR agonist, orally administration (10 mg) Assignment of treatment (placebo and obeticholic acid) will be randomized before study visit 1. Either placebo or obeticholic acid will be administered orally in a single-blind fashion for 21 days. After a washout period of 28 days, either placebo or obeticholic acid will be administered as appropriate for an additional 21 days.

Drug: Ocaliva

Placebo

PLACEBO COMPARATOR

Assignment of treatment (placebo and obeticholic acid) will be randomized before study visit 1. Either placebo or obeticholic acid will be administered orally in a single-blind fashion for 21 days. After a washout period of 28 days, either placebo or obeticholic acid will be administered as appropriate for an additional 21 days.

Drug: Placebo

Interventions

OcalivaDRUG

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

Also known as: obeticholic acid
Obeticholic acid
PlaceboDRUG

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.

Also known as: Placebo Oral Tablet (Starch)
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
  • Subject is between 18 and 65 years of age
  • Subject has a BMI between 18 and 25 kg/m²

You may not qualify if:

  • Participant has a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies, diabetes, a significant heart, lung, liver or kidney disease, a neurological disorder, abdominal surgery (including gallbladder removal, but those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate),
  • Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
  • Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
  • Participation in an interventional Trial with an investigational medicinal product (IMP) or device
  • High caffeine intake (\> 500 ml coffee daily or equivalent).
  • Subject consumes excessive amounts of alcohol, defined as \>21 units per week for men, \>14 units per week for women.
  • Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
  • Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
  • Recent participation (\<30 days) or simultaneous participation in another clinical study.
  • Prior participation in a clinical trial of obeticholic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

obeticholic acidStarch

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Central Study Contacts

Jan Tack, PhD, MD

CONTACT

03216345514jan.tack@med.kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Division of Gastroenterology and Hepatology, Leuven University

Study Record Dates

First Submitted

September 16, 2022

First Posted

February 23, 2023

Study Start

August 22, 2022

Primary Completion

July 22, 2023

Study Completion

July 22, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

BE(1)