drugset / Trial / NCT01716234

A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

NCT01716234

Phase 1 Terminated 142 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.

Timeline

Start
2008-04-17
Primary completion
2015-04-01
Completion
2015-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Posaconazole Small molecule 12 mg/kg Oral
Subject Posaconazole Small molecule 18 mg/kg Oral