Gastric Motility
Conditions
Keywords
gastric motility
Brief summary
The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.
Interventions
DRUGRelamorelin
Double blind RM-131 will be delivered three times by injection during the course of the study
DRUGPlacebo
Double blind Placebo will be delivered three times by injection during the course of the study
Sponsors
Mayo Clinic
Motus Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures 2. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus 3. Body mass index of 18-35 kg/m² 4. 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
1. Unable or unwilling to provide informed consent or to comply with study procedures 2. Diagnosis of gastrointestinal diseases 3. Structural or metabolic diseases that affect the GI system 4. Unable to avoid the following over- the- counter medications 48 hours prior to the baseline period and throughout the study: 1. Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, 2. 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. 5. History of recent surgery (within 60 days of screening) 6. 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. 7. Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator 8. Acute GI illness within 48 hours of initiation of the baseline period 9. Females who are pregnant or breastfeeding 10. History of excessive alcohol use or substance abuse 11. Participation in an investigational study within the 30 days prior to dosing in the present study 12. Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric volume measured by single photon emission computed tomography (SPECT) | Measured during the 1 hour study procedure | Calculation of gastric volume by single photon emission computed tomography (SPECT) |
| Satiety measured by the Hunger/Satiety questionnaire | Measured during a 1 hour study procedure | Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink |
| Gastric motility measured by gastroduodenal manometry | Measured during the 4 hour study procedure | Measurement of gastric motility by gastroduodenal manometry |
Countries
United States
Outcome results
None listed