NCT00686543

Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)

A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients With Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.

Conditions

• Fungal Infection
• Acute Myelogenous Leukemia
• Neutropenia

Interventions

Type	Name	Description
DRUG	Posaconazole	Posaconazole will be used for prophylaxis

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-05-30
• Last updated: 2017-04-07
• Results posted: 2010-05-14