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

NCT ID: NCT02466711

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Gastric Motility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Relamorelin

Group Type: ACTIVE_COMPARATOR

Relamorelin

Intervention Type: DRUG

Double blind RM-131 will be delivered three times by injection during the course of the study

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Double blind Placebo will be delivered three times by injection during the course of the study

Interventions

Relamorelin

Double blind RM-131 will be delivered three times by injection during the course of the study

Intervention Type: DRUG

Placebo

Double blind Placebo will be delivered three times by injection during the course of the study

Intervention Type: DRUG

Other Intervention Names

RM-131

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Motus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Camilleri, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27283792 (View on PubMed)

Other Identifiers

RM-131-010

Identifier Type: -

Identifier Source: org_study_id