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

Phase 1

Completed

• Conditions: Gastric Motility
• Interventions: Drug: Placebo; Drug: Relamorelin

• Registration Number: NCT02466711
• Lead Sponsor: Motus Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-09
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Relamorelin	Relamorelin	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States