Overview

Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepitant at certain timepoints.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Aprepitant
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fosaprepitant
Ondansetron
Criteria
Inclusion Criteria:

- Generally healthy

- Female participants must be of non-childbearing potential

- Non-smoker or has not used nicotine or nicotine-containing products for at least 6
months

Exclusion Criteria:

- History of a clinically significant psychiatric disorder over the last 5 to 10 years

- History of stroke, chronic seizures, or major neurological disorder

- History of clinically significant endocrine, gastrointestinal, cardiovascular,
hematological, hepatic, immunological, renal, respiratory, or genitourinary
abnormalities or diseases

- History of neoplastic disease

- Excessive consumption of alcohol (3 drinks/day) or caffeinated beverages (6
servings/day)

- Major surgery, donated or lost 1 unit of blood within 4 weeks

- Participated in another investigational study within 4 weeks

- History of significant drug allergy or any clinically significant adverse

experiences related to EMENDâ„¢, dexamethasone, or ondansetron

- History of significant multiple and/or severe allergies

- History of anaphylactic reaction or significant intolerability to prescription or
non-prescription drugs or food

- Current drug/alcohol abuse, or history of such within 2 years

- Participation in a PET study or other study involving administration of a radioactive
substance or ionizing radiation within the prior 12 months

- Extensive radiological examination within the prior 12 months

- Magnetizable metal prostheses or devices (Magnetic Resonance Imaging (MRI) hazard)

- History of claustrophobia