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

NCT02466711 | Completed Phase 1

• 1 other identifier: RM-131-010
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

gastric motility

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Relamorelin

ACTIVE COMPARATOR

Drug: Relamorelin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Relamorelin DRUG

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

Also known as: RM-131

Relamorelin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
• No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
• Body mass index of 18-35 kg/m²
• 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 \[defined as a minimum of one year since the last menstrual period\]).

You may not qualify if:

• Unable or unwilling to provide informed consent or to comply with study procedures
• Diagnosis of gastrointestinal diseases
• Structural or metabolic diseases that affect the GI system
• Unable to avoid the following over- the- counter medications 48 hours prior to the baseline period and throughout the study:
• Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin,
• 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.
• History of recent surgery (within 60 days of screening)
• 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.
• Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator
• Acute GI illness within 48 hours of initiation of the baseline period
• Females who are pregnant or breastfeeding
• History of excessive alcohol use or substance abuse
• Participation in an investigational study within the 30 days prior to dosing in the present study
• Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study

Sponsors & Collaborators

• Motus Therapeutics, Inc.: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Location

Related Publications (1)

• 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.

  PMID: 27283792 DERIVED

MeSH Terms

Interventions

relamorelin

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

US (1)