Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:12/14/2018
Start Date:January 27, 2017
End Date:January 1, 2018

Use our guide to learn which trials are right for you!

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

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.


Inclusion criteria:

1. Able to provide written consent

2. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus

3. Body Mass Index of 18-35 kg/m^2

4. Female subjects must have negative urine pregnancy tests and must not be lactating
prior to receiving study medication and radiation exposure

5. 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

6. 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. Diagnosis of gastrointestinal diseases

2. Structural or metabolic diseases that affect the gastrointestinal system

3. Unable to avoid the following over-the-counter medications 48 hours prior to the
baseline period and throughout the study:

- Medications that alter GI transit including laxatives, magnesium and aluminum
containing antacids, prokinetics, erythromycin

- Analgesic drugs including NSAIDs and cyclooxygenase-2 (COX-2) inhibitor. (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.)

4. History of recent surgery (within 60 days of screening).

5. 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.

6. Any clinically significant abnormalities on physical examination or laboratory
abnormalities identified in the medical record, as determined by the investigator.

7. Acute GI illness within 48 hours of initiation of the baseline period.

8. Females who are pregnant or breastfeeding.

9. History of excessive alcohol use or substance abuse.

10. Participation in an investigational study within the 30 days prior to dosing in the
present study.

11. Any other reason, which in the opinion of the investigator would confound proper
interpretation of the study.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials