NCT00818259

A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Experimental: aprepitant	aprepitant powder for suspension, 125 mg/sachet, PO
DRUG	Experimental: fosaprepitant	fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV
DRUG	Comparator: ondansetron	ondansetron solution for infusion, IV, administered per local standard of care
DRUG	Ondansetron	ondansetron solution for infusion, IV, administered per local standard of care
DRUG	Dexamethasone	dexamethasone solution for infusion, IV, administered per local standard of care

Timeline

• Start date: 2009-02-05
• Primary completion: 2014-01-20
• Completion: 2014-01-20
• First posted: 2009-01-07
• Last updated: 2018-09-25
• Results posted: 2014-11-18