Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying (NCT02989467) | Clinical Trial Compass
CompletedPhase 1
Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying
United States27 participantsStarted 2017-01-27
Plain-language summary
This research study is being done to compare the effects of Aprepitant and placebo on fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to provide written consent
. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
. Body Mass Index of 18-35 kg/m\^2
. 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
. Diagnosis of gastrointestinal diseases
. Structural or metabolic diseases that affect the gastrointestinal system
. Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gastric Emptying Half-Time of Solids as Measured by Scintigraphy
Timeframe: Day 3, approximately 2 hours after radiolabeled meal is ingested
2
Satiation Expressed as Volume to Fullness
Timeframe: Day 4, approximately 30 minutes after liquid meal
3
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
Timeframe: Day 5, approximately 15 minutes after radioactive marker is administered
4
Postprandial Gastric Volume as Measured by SPECT
Timeframe: Day 5, approximately 30 minutes after liquid meal
5
Accommodation Volume as Measured by SPECT
Timeframe: Day 5, approximately 30 minutes after liquid meal
. 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.