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

Fungal infection

Average concentration (Cavg) of single-dose IV POS (Panel A), Maximum concentration (Cmax) of single-dose IV POS (Panel A), Time to maximum concentration (Tmax) of single-dose IV POS (Panel A), Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A), Clearance (CL) of single-dose IV POS (Panel A), Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A), Cavg of multiple-dose IV POS (Panel B), Cmax of multiple-dose IV POS (Panel B), Tmax of multiple-dose IV POS (Panel B), AUC0-24 of multiple-dose IV POS (Panel B), CL of multiple-dose IV POS (Panel B), Cavg of multiple-dose PFS (Panel B), Cmax of multiple-dose PFS (Panel B), AUC0-24 of multiple-dose PFS (Panel B)

Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B only), Percentage of participants with ≥1 adverse events (AEs) [Panels A and B], Percentage of participants with ≥1 drug-related AEs (Panels A and B), Percentage of participants discontinuing from study treatment due to AE(s) (Panels A and B), Percentage of participants with all-cause mortality through 28 days (Panel B), Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period [Panel B]

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Belgium, Greece, Poland