E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study will focus on the underlying mechanisms of gastrointestinal motility and gut microbiota in healthy subjects. |
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E.1.1.1 | Medical condition in easily understood language |
The study will focus on the underlying mechanisms of gastrointestinal motility and gut microbiota in healthy subjects. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Microbiological Phenomena [G06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017782 |
E.1.2 | Term | Gastric emptying study |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061247 |
E.1.2 | Term | Intestinal functional disorder |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To detect changes in appetite/hunger after administration of obeticholic acid compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
(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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
- Appetite-related sensations compared between placebo and treatment with obeticholic acid |
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E.5.1.1 | 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. |
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E.5.2 | 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
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
This study will cover physiological effects (gut microbiota, gastric motility, gastrointestinal hormones, hunger feelings,...). |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |