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A Multicenter, Open-Label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy
This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.
Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after intravenous administration; the pharmacological effect of fosaprepitant is attributed to aprepitant. The birth to one year old cohort will be initiated in Parts III and IV upon completion of Part II (Steps A and B) in participants \<6 months of age.
Age
0 - 17 years
Sex
ALL
Healthy Volunteers
No
Start Date
February 5, 2009
Primary Completion Date
January 20, 2014
Completion Date
January 20, 2014
Last Updated
September 25, 2018
92
ACTUAL participants
Experimental: aprepitant
DRUG
Experimental: fosaprepitant
DRUG
Comparator: ondansetron
DRUG
Ondansetron
DRUG
Dexamethasone
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT02106494
NCT01937156
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04472143