Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.

Official Title
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A Single-center, Placebo-controlled, Double-blind Study to Evaluate the Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers

Conditions
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Gastric Motility

Intervention / Treatment
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* Drug: Relamorelin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus Body mass index of 18-35 kg/m² Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). Exclusion Criteria: Unable or unwilling to provide informed consent or to comply with study procedures Diagnosis of gastrointestinal diseases Structural or metabolic diseases that affect the GI system Unable to avoid the following over- the- counter medications 48 hours prior to the baseline period and throughout the study: Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, Analgesic drugs including NSAIDs and COX-2 inhibitors NOTE: stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible. History of recent surgery (within 60 days of screening) Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc. Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator Acute GI illness within 48 hours of initiation of the baseline period Females who are pregnant or breastfeeding History of excessive alcohol use or substance abuse Participation in an investigational study within the 30 days prior to dosing in the present study Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Relamorelin<br> | Drug: Relamorelin<br>* Double blind RM-131 will be delivered three times by injection during the course of the study<br>* Other names: RM-131;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Double blind Placebo will be delivered three times by injection during the course of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume measured by single photon emission computed tomography (SPECT) | Calculation of gastric volume by single photon emission computed tomography (SPECT) | Measured during the 1 hour study procedure | 
| Satiety measured by the Hunger/Satiety questionnaire | Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink | Measured during a 1 hour study procedure | 
| Gastric motility measured by gastroduodenal manometry | Measurement of gastric motility by gastroduodenal manometry | Measured during the 4 hour study procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric motility