Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying
NCT ID: NCT02989467
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2017-01-27
2018-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aprepitant
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.
Aprepitant
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.
Placebo
Subjects will receive one placebo tablet daily for 5 consecutive days.
Placebo
Subjects will receive one placebo tablet daily for 5 consecutive days.
Interventions
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Aprepitant
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.
Placebo
Subjects will receive one placebo tablet daily for 5 consecutive days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Michael Camilleri, MD
Professor, College of Medicine
Principal Investigators
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Michael Camilleri
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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16-007929
Identifier Type: -
Identifier Source: org_study_id