Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT02989467
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.
Other names: Emend
Subjects will receive one placebo tablet daily for 5 consecutive days.
Time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
The time for half of the ingested solids to leave the stomach.
Time frame: Day 4, approximately 30 minutes after liquid meal
Subjects will do a satiation/nutrient drink test, consuming Ensure at a relatively constant rate of 30 ml/min. Subjects will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 3.
Time frame: Day 5, approximately 15 minutes after radioactive marker is administered
Subjects will arrive to the Clinical Research and Trials Unit (CRTU) fasting. A radioactive marker will be administered intravenously. After a 10-15 minute wait period a fasting scan will be acquired using a dual-head gamma camera.
Time frame: Day 5, approximately 30 minutes after liquid meal
At the completion of the fasting scan, the subject will consume 300 ml of Ensure followed by a postprandial scan using a dual-head gamma camera.
Time frame: Day 5, approximately 30 minutes after liquid meal
This variable is calculated as postprandial gastric volume minus fasting volume.
Time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.
Time frame: Day 3, approximately 4 hours after radiolabeled meal is ingested
On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 4 hours.
Time frame: Day 4, approximately 30 minutes after liquid meal
On Day 4, subjects will do a satiation/nutrient drink test. Participants will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 5.
Time frame: Day 4, approximately 30 minutes after liquid meal
Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end.
Time frame: Day 4, approximately 1 hour after liquid meal
Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end. The aggregate symptoms score is calculated by adding the mean individual scores. The lowest possible score would be 0 (none) and the highest maximum score possible is 400 (worst ever).
Time frame: Day 5, approximately 1 hour after radioactive marker is administered
Postprandial/fasting gastric volume
Time frame: Day 5, approximately 1 hour after radioactive marker is administered
This is the total postprandial gastric volume
Mayo Clinic
Other
A Single-Center, Placebo-Controlled, Double-Blind Study to Evaluate the Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details