Trials / Completed

CompletedNCT02452034

Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)

A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects With Neutropenia

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 118 (actual)

Sponsor: Merck Sharp & Dohme LLC · Industry
Sex: All
Age: 2 Years – 17 Years
Healthy volunteers: Not accepted

Summary

This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.

Conditions

Neutropenia

Interventions

Type	Name	Description
DRUG	Posaconazole IV solution	Posaconazole by IV solution twice on Day 1, then once daily on Days 2-10.
DRUG	Posaconazole powder for oral suspension	Posaconazole once daily by PFS for a minimum of 10 days

Timeline

Start date: 2015-09-07
Primary completion: 2018-06-26
Completion: 2018-09-03
First posted: 2015-05-22
Last updated: 2019-07-26
Results posted: 2019-07-26

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02452034. Inclusion in this directory is not an endorsement.