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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relamorelin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relamorelin | Drug | Double blind RM-131 will be delivered three times by injection during the course of the study |
|
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Rochester | Rochester | Minnesota | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27283792 | Derived | Nelson AD, Camilleri M, Acosta A, Busciglio I, Linker Nord S, Boldingh A, Rhoten D, Ryks M, Burton D. Effects of ghrelin receptor agonist, relamorelin, on gastric motor functions and satiation in healthy volunteers. Neurogastroenterol Motil. 2016 Nov;28(11):1705-1713. doi: 10.1111/nmo.12870. Epub 2016 Jun 9. |
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| ID | Term |
|---|---|
| C000593860 | relamorelin |
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| Placebo | Drug | Double blind Placebo will be delivered three times by injection during the course of the study |
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