NCT04665037

Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 1 Day – 2 Years
• Healthy volunteers: Not accepted

Summary

This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants \<2 years of age with invasive fungal infection (IFI).

Detailed description

There are 2 panels in this study. In Panel A, POS IV will be evaluated in ≥8 participants. In Panel B, both POS IV and POS PFS will be evaluated in ≥14 participants, including ≥6 who are \<3 months of age and ≥5 who transition to the PFS formulation of POS.

Conditions

• Invasive Fungal Infection

Interventions

Type	Name	Description
DRUG	Posaconazole IV 6 mg/kg	POS 6 mg/kg body weight by IV infusion
DRUG	Posaconazole PFS 6 mg/kg	POS nominal 6 mg/kg body weight based on weight bands taken orally

Timeline

• Start date: 2022-02-22
• Primary completion: 2026-12-16
• Completion: 2026-12-31
• First posted: 2020-12-11
• Last updated: 2025-09-18

Locations

26 sites across 10 countries: United States, Belgium, Greece, Israel, Mexico, Peru, Poland, Russia, South Korea, Ukraine

Regulatory

• FDA-regulated drug study