CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 230 enrolled
Drug / intervention
Posaconazole 200 mg +1 moredrug
Likely dose
Posaconazole 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01777763
NCT01777763Phase 1Completed

Pharmacokinetics and Safety of Solid Oral Posaconazole (SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05615)

Merck Sharp & Dohme LLC·interventional·Posted Jan 29, 2013·Updated Apr 7, 2017

In Brief

A Phase 1 clinical trial evaluating Posaconazole 200 mg and Posaconazole 300 mg for Fungal Infections. Completed, enrolled 230 participants.

Detailed Summary

The purpose of this study is to collect pharmacokinetic (PK) information related to how well posaconazole tablet is distributed in the body and to determine the safety of this new formulation. The study consists of a Phase 1B study that includes participants with neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant (HSCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2013
Enrollment StartJun 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.4 years ago

Interventions

Posaconazole 200 mgdrug

Posaconazole 300 mgdrug