Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
Condition: Chemotherapy-Induced Nausea and Vomiting (CINV)
MeSH terms: Vomiting
Intervention: Fosaprepitant 150 mg; Aprepitant 165 mg; Aprepitant 250 mg; Dexamethasone (12-8-16-16 mg); Dexamethasone (12-8-8-16 mg); Ondansetron; MK0999
Intervention description: a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal; a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal; a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal; Dexamethasone 12 mg will be administered orally 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg twice daily), and Day 4 (8 mg twice daily) with or without a meal.; Dexamethasone 12 mg will be administered orally 30 minutes after after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg), and Day 4 (8 mg twice daily) with or without a meal.; The intravenous (I.V.) infusion of ondansetron 32 mg will begin 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1 and will be administered as a 15-minute infusion; I.V. infusion of MK0999 containing ~100 MBq (~3 mCi) containing ≤ 5 ug of MK0999)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; Fosaprepitant; BB 1101
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: NK1-receptor occupancy

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.
    

Eligibility 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