A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; Fosaprepitant; Midazolam

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