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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00990821 |
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Date of registration:
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06/10/2009 |
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Primary sponsor: |
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Public title:
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A Study to Investigate the Safety and Tolerability of MK0517 in Healthy Subjects
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Scientific title:
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A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00990821 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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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 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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chemotherapy-Induced Nausea and Vomiting
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Postoperative Nausea and Vomiting
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Intervention(s)
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Drug: Comparator: aprepitant 125mg
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Drug: Comparator: aprepitant 40 mg
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Drug: Comparator: midazolam
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Drug: MK0517
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Primary Outcome(s)
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Plasma Area Under the Curve (AUC(0 to infinity)) for Aprepitant
[Time Frame: 72 Hours Post Dose]
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Secondary ID(s)
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2009_671
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MK0517-012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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