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

Sponsor
Motus Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02466711
Collaborator
Mayo Clinic (Other)
16
Enrollment
1
Location
2
Arms
3
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Placebo Comparator: Placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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

    3. Gastric motility measured by gastroduodenal manometry [Measured during the 4 hour study procedure]

      Measurement of gastric motility by gastroduodenal manometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    5. Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin,

    6. 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.

    7. History of recent surgery (within 60 days of screening)

    8. 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.

    9. Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator

    10. Acute GI illness within 48 hours of initiation of the baseline period

    11. Females who are pregnant or breastfeeding

    12. History of excessive alcohol use or substance abuse

    13. Participation in an investigational study within the 30 days prior to dosing in the present study

    14. Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic - Rochester Rochester Minnesota United States

    Sponsors and Collaborators

    • Motus Therapeutics, Inc.
    • Mayo Clinic

    Investigators

    • Principal Investigator: Michael Camilleri, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Motus Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02466711
    Other Study ID Numbers:
    • RM-131-010
    First Posted:
    Jun 9, 2015
    Last Update Posted:
    Sep 22, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Motus Therapeutics, Inc.
    gastric motility

    Study Results

    No Results Posted as of Sep 22, 2016