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 EMEND™, 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