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 range18 Years – 65 Years

SexALL

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:
✕. 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.

What they're measuring

Gastric Emptying Half-Time of Solids as Measured by Scintigraphy

Timeframe: Day 3, approximately 2 hours after radiolabeled meal is ingested

Satiation Expressed as Volume to Fullness

Timeframe: Day 4, approximately 30 minutes after liquid meal

Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)

Timeframe: Day 5, approximately 15 minutes after radioactive marker is administered

Postprandial Gastric Volume as Measured by SPECT

Timeframe: Day 5, approximately 30 minutes after liquid meal

Accommodation Volume as Measured by SPECT

Timeframe: Day 5, approximately 30 minutes after liquid meal

Trial details

NCT IDNCT02989467

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-20

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range18 Years – 65 Years

SexALL

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:
✕. 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.

What they're measuring

Gastric Emptying Half-Time of Solids as Measured by Scintigraphy

Timeframe: Day 3, approximately 2 hours after radiolabeled meal is ingested

Satiation Expressed as Volume to Fullness

Timeframe: Day 4, approximately 30 minutes after liquid meal

Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)

Timeframe: Day 5, approximately 15 minutes after radioactive marker is administered

Postprandial Gastric Volume as Measured by SPECT

Timeframe: Day 5, approximately 30 minutes after liquid meal

Accommodation Volume as Measured by SPECT

Timeframe: Day 5, approximately 30 minutes after liquid meal