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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant | Active Comparator | 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. |
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| Placebo | Placebo Comparator | Subjects will receive one placebo tablet daily for 5 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastric Emptying Half-Time of Solids as Measured by Scintigraphy | The time for half of the ingested solids to leave the stomach. | Day 3, approximately 2 hours after radiolabeled meal is ingested |
| Satiation Expressed as Volume to Fullness | 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. | Day 4, approximately 30 minutes after liquid meal |
| Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) | 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. | Day 5, approximately 15 minutes after radioactive marker is administered |
| Postprandial Gastric Volume as Measured by SPECT | 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. | Day 5, approximately 30 minutes after liquid meal |
| Accommodation Volume as Measured by SPECT | This variable is calculated as postprandial gastric volume minus fasting volume. | Day 5, approximately 30 minutes after liquid meal |
| Measure | Description | Time Frame |
|---|---|---|
| Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours | 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. |
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Inclusion criteria:
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.
History of excessive alcohol use or substance abuse.
Participation in an investigational study within the 30 days prior to dosing in the present study.
Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Subjects will receive one placebo tablet daily for 5 consecutive days. |
|
| Day 3, approximately 2 hours after radiolabeled meal is ingested |
| Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours | 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. | Day 3, approximately 4 hours after radiolabeled meal is ingested |
| Maximum Tolerated Volume on Satiation Test | 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. | Day 4, approximately 30 minutes after liquid meal |
| Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test | 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. | Day 4, approximately 30 minutes after liquid meal |
| Aggregate Symptoms Score | 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). | Day 4, approximately 1 hour after liquid meal |
| Gastric Volume Ratio | Postprandial/fasting gastric volume | Day 5, approximately 1 hour after radioactive marker is administered |
| Absolute postprandial gastric volume | This is the total postprandial gastric volume | Day 5, approximately 1 hour after radioactive marker is administered |