Current partner codePEPTIDESDE
NCT02466711·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

16

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

Relamorelin

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

DRUG

Placebo

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

Timeline

From registration to results.

  1. First posted

    Jun 9, 2015

  2. Study start

    Jun 2015

  3. Primary completion

    Aug 2015

  4. Study completion

    Sep 2015

  5. Results posted

    Not reported

  6. Registry updated

    Sep 22, 2016

Outcomes

What the study measures.

Primary outcomes

Gastric volume measured by single photon emission computed tomography (SPECT)

Time frame · Measured during the 1 hour study procedure

Calculation of gastric volume by single photon emission computed tomography (SPECT)

Satiety measured by the Hunger/Satiety questionnaire

Time frame · Measured during a 1 hour study procedure

Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink

Gastric motility measured by gastroduodenal manometry

Time frame · Measured during the 4 hour study procedure

Measurement of gastric motility by gastroduodenal manometry

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
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: 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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Related trials

More studies on Relamorelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.