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

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

Outcome

Outcome not reported

Stopped: “Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.”

Publications

Arrieta AC, Sung L, Bradley JS, Zwaan CM, Gates D, Waskin H, Carmelitano P, Groll AH, Lehrnbecher T, Mangin E, Joshi A, Kartsonis NA, Walsh TJ, Paschke A. A non-randomized trial to assess the safety, tolerability, and pharmacokinetics of posaconazole oral suspension in immunocompromised children with neutropenia. PLoS One. 2019 Mar 26;14(3):e0212837. doi: 10.1371/journal.pone.0212837. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Posaconazole	Small molecule	12 mg/kg	Oral
Subject	Posaconazole	Small molecule	18 mg/kg	Oral