Clinical trial NCT02989467: Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastric Emptying Half-Time of Solids as Measured by Scintigraphy
timeFrame: Day 3, approximately 2 hours after radiolabeled meal is ingested
measure: Satiation Expressed as Volume to Fullness
timeFrame: Day 4, approximately 30 minutes after liquid meal
measure: Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
timeFrame: Day 5, approximately 15 minutes after radioactive marker is administered
measure: Postprandial Gastric Volume as Measured by SPECT
timeFrame: Day 5, approximately 30 minutes after liquid meal
measure: Accommodation Volume as Measured by SPECT
timeFrame: Day 5, approximately 30 minutes after liquid meal
Secondary outcomes:
measure: Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours
timeFrame: Day 3, approximately 2 hours after radiolabeled meal is ingested
measure: Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours
timeFrame: Day 3, approximately 4 hours after radiolabeled meal is ingested
measure: Maximum Tolerated Volume on Satiation Test
timeFrame: Day 4, approximately 30 minutes after liquid meal
measure: Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test
timeFrame: Day 4, approximately 30 minutes after liquid meal
measure: Aggregate Symptoms Score
timeFrame: Day 4, approximately 1 hour after liquid meal
measure: Gastric Volume Ratio
timeFrame: Day 5, approximately 1 hour after radioactive marker is administered
measure: Absolute postprandial gastric volume
timeFrame: Day 5, approximately 1 hour after radioactive marker is administered
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri
role: PRINCIPAL_INVESTIGATOR
References: