Overview

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