A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
Condition: Chemotherapy-Induced Nausea and Vomiting; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: 90 mg MK-0517 (PS80); 100 mg MK-0517 (PS80); 100 MK-0517 (PS80) + 2 mg midazolam; 115 mg MK-0517 (PS80); 150 mg MK-0517 (PS80); 40 mg MK-0517 (non-PS80); 100 mg MK-0517 (non-PS80); 150 mg MK-0517 (Non-PS80); Placebo; 40 mg Aprepitant; 125 mg Aprepitant; 2 mg Midazolam
Intervention description: MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes; MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes; MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.; MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes; MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes; MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.; MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.; MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.; Placebo matching MK-0517; Aprepitant, oral, tablet, single dose; Aprepitant oral tablet, single dose; Midazolam oral tablet, single dose
Intervention MeSH terms: Midazolam; Aprepitant; Fosaprepitant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two
      formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults.
      Parts I to IV of this study will examine different doses of MK-0517 as well as two different
      formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare
      single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The
      primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or
      115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg
      oral aprepitant capsule in young healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is neither grossly overweight nor underweight for his/her height and body
             build

          -  Subject is in good health -Subject is a nonsmoker

          -  Subject is willing to avoid excessive alcohol consumption for the duration of the
             study

          -  Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight
             lifting, running, bicycling) for the duration of the study

          -  Subject agrees to refrain from consumption of grapefruit (and grapefruit products)
             before and during the study

        Exclusion Criteria:

          -  Subject has a history of multiple and/or severe allergies to drugs or food

          -  Subject has donated blood or taken an investigational drug in another clinical trial
             within the last 4 weeks

          -  Subject has an infection, including Human immunodeficiency virus (HIV) infection

          -  Subject is a regular user of any illicit drug

          -  Subject consumes excessive amounts of alcohol

          -  Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages

          -  Subject currently uses on a regular basis, any prescription or non prescription
             medications