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).
Panel A: is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)
Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis)
Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study intervention.
Has a body weight of ≥500 g
Has received POS within 30 days before Day 1
Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Has known or suspected active COVID-19 infection
Sequential
Posaconazole IV 6 mg/kg
DrugPOS 6 mg/kg body weight by IV infusion
Posaconazole PFS 6 mg/kg
DrugPOS nominal 6 mg/kg body weight based on weight bands taken orally
Average concentration (Cavg) of single-dose IV POS (Panel A)
The Cavg of IV POS is based on population PK analysis.
Maximum concentration (Cmax) of single-dose IV POS (Panel A)
The Cmax of IV POS is based on population PK analysis.
Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)
The Tmax of IV POS is based on population PK analysis.
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)
The AUC 0-24 of IV POS is based on population PK analysis.
Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B)
The Cavg of IV POS is based on population PK analysis. Comparisons between participants in Panel B will be made to data that was previously collected in older participants.
Percentage of participants with an ≥ 1 adverse event (AE) [Panels A and B]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants who discontinued study therapy due to an AE (Panels A and B)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants with a drug-related AE (Panels A and B)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Click on the lead sponsor to view all of their trials.