The study will focus on the underlying mechanisms of gastrointestinal motility and gut microbiota in healthy subjects. MedDRA version: 21.0 Level: PT Classification code 10017782 Term: Gastric emptying study System Organ Class: 10022891 - Investigations MedDRA version: 20.1 Level: LLT Classification code 10061247 Term: Intestinal functional disorder System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Ocaliva
Pharmaceutical Form: Tablet
INN or Proposed INN: obeticholic acid
CAS Number: 459789-99-2
Current Sponsor code: 6-ECDCA
Other descriptive name: OBETICHOLIC ACID
Concentration unit:
Sponsors
KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is between 18 and 65 years of age. - Subject has a BMI between 18 and 25 kg/m² - Subject understands the study procedures and agrees to participate in the study and to comply with medical regimen by giving written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Inclusion criteria - Subject is between 18 and 65 years of age. - Subject has a BMI between 18 and 25 kg/m² - Subject understands the study procedures and agrees to participate in the study and to comply with medical regimen by giving written informed consent. Exclusion criteria - Subject is under age of legal consent, pregnant or breastfeeding. - Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies. - Subject with a BMI = 18 kg/m² or BMI = 25 kg/m². - Subject has history of presence of diabetic or metabolic disease . - Subject has a significant heart, lung, liver or kidney disease. - Subject has any history of a neurological disorder. - Subject has a history of abdominal or other gastrointestinal surgery (including gallbladder removal). Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate. - Current use of drugs that can affect gastrointestinal function, motility or sensitivity or gastric acidity and bile acid metabolism. - Current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit). - Current use of warfarin - Current use of proton pump inhibitors - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To detect changes in appetite/hunger after administration of obeticholic acid compared to placebo.;Secondary Objective: (1)To detect changes in the release of gastrointestinal peptide after administration of obeticholic acid compared to placebo. (2)To detect changes in gastric motility, accommodation after administration of obeticholic acid compared to placebo. (3)To detect changes in gut microbiota after administration of obeticholic acid compared to placebo. ;Primary end point(s): -Appetite-related sensations compared between placebo and treatment with obeticholic acid;Timepoint(s) of evaluation of this end point: The volunteers have 8 visits for this study. A motility test and an endoscopy are performed before and at end of each treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Gastrointestinal hormone release compared between placebo and treatment with obeticholic acid - Gastric motility, accommodation compared between placebo and treatment with obeticholic acid - changes in gut microbial diversity abundance of specific bacteria compared between placebo and treatment with obeticholic acid ;Timepoint(s) of evaluation of this end point: The volunteers have 8 visits for this study. A motility test and an endoscopy are performed before and at end of each treatment. | — |
Countries
Belgium
Contacts
Public ContactClinical Trials into TARGID
KU Leuven
Outcome results
None listed