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

NCT02452034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2019-07-26

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-07
Primary Completion
2018-06-26
Completion
2018-09-03
FDA Drug
Yes

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452034 on ClinicalTrials.gov