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

NCT02989467 | Completed Phase 1 FDA Drug

• 1 other identifier: 16-007929
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (7)

• Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours

  Day 3, approximately 2 hours after radiolabeled meal is ingested

• Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours

  Day 3, approximately 4 hours after radiolabeled meal is ingested

• Maximum Tolerated Volume on Satiation Test

  Day 4, approximately 30 minutes after liquid meal

• Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test

  Day 4, approximately 30 minutes after liquid meal

• Aggregate Symptoms Score

  Day 4, approximately 1 hour after liquid meal

Study Arms (2)

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.

Drug: Aprepitant

Placebo

PLACEBO COMPARATOR

Subjects will receive one placebo tablet daily for 5 consecutive days.

Drug: Placebo

Interventions

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.

Also known as: Emend

Aprepitant

Placebo DRUG

Subjects will receive one placebo tablet daily for 5 consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written consent
• No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
• Body Mass Index of 18-35 kg/m\^2
• Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure
• 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
• Female subjects unable to bear children must have this documented in the medical record (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since the last menstrual period\])

You may not qualify if:

• 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:
• 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.)
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Aprepitant

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Camilleri

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Medicine

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 12, 2016
• Study Start: January 27, 2017
• Primary Completion: November 20, 2017
• Study Completion: January 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)