- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05740631
The Effect of Obeticholic Acid in Healthy Volunteers (OCARINA)
The Effect of Obeticholic Acid on Gut Microbiota, Gastric Motility, Accommodation, Gastrointestinal Peptide in Healthy Volunteers
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.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jan Tack, PhD, MD
- Phone Number: 03216345514
- Email: jan.tack@med.kuleuven.be
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- Recruiting
- KU Leuven
-
Contact:
- Jan Tack, PhD, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Obeticholic acid
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. |
Assignment of treatment obeticholic acid will be started (randomized) after the study visit and administered orally in a single-blind fashion for 21 days.
Other Names:
|
Placebo Comparator: Placebo
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in appetite after administration of obeticholic acid compared to placebo
Time Frame: During MMCⅢ (300 min)
|
Assessment by questionnaire(100mm Visual Analogue Scale) every 10 minutes.
|
During MMCⅢ (300 min)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum GI hormones concentrations
Time Frame: During MMCⅢ (300 min)
|
Blood samples to assess GI hormones concentrations
|
During MMCⅢ (300 min)
|
Change in gastric motility
Time Frame: During MMCⅢ (300 min)
|
IGP(Intragastric pressure) will be measured.
|
During MMCⅢ (300 min)
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Change in gut microbiota
Time Frame: 12 days
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Stool samples will be collected for analyze gut microbiota.
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12 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S64643
- 2020-004180-13 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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