Status:
COMPLETED
A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chemotherapy-Induced Nausea and Vomiting
Postoperative Nausea and Vomiting
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00990821
Start Date
January 1 2005
End Date
January 1 2006
Last Update
August 19 2015
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