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

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

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

Study Overview

• Status: Completed
• Conditions: Gastric Motility
• Intervention / Treatment: Drug: Relamorelin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States
      • Mayo Clinic - Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Motus Therapeutics, Inc.
• Collaborators: Mayo Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: gastric motility
• Other Study ID Numbers: RM-131-010