At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 118 enrolled
Drug / intervention
Posaconazole IV solution +1 moredrug
Likely dose
Not stated in 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.
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
In Brief
A Phase 1 clinical trial evaluating Posaconazole IV solution and Posaconazole powder for oral suspension for Neutropenia. Completed, enrolled 118 participants.
Detailed Summary
This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeutropenia
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartSep 2015
Primary CompletionJun 2018
Study CompletionSep 2018
TodayJul 2026
First PostedMay 22, 2015
Enrollment StartSep 7, 2015
Primary CompletionJun 26, 2018
Study CompletionSep 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.1 years ago
Interventions
Posaconazole IV solutiondrug
Posaconazole by IV solution twice on Day 1, then once daily on Days 2-10.
Posaconazole powder for oral suspensiondrug
Posaconazole once daily by PFS for a minimum of 10 days