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

Gastric Motility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466711
• Other study ID #: RM-131-010
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2015
• Last updated: September 21, 2016
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Motus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastric Motility

Intervention

Drug:
• Relamorelin
Double blind RM-131 will be delivered three times by injection during the course of the study
• Placebo
Double blind Placebo will be delivered three times by injection during the course of the study

Locations

Country	Name	City	State
United States	Mayo Clinic - Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Motus Therapeutics, Inc.	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Gastric motility measured by gastroduodenal manometry	Measurement of gastric motility by gastroduodenal manometry	Measured during the 4 hour study procedure	No