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
Merck Sharp & Dohme LLC
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).
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.
Eligibility
- Age range
- 0–2 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugPosaconazole IV 6 mg/kg
POS 6 mg/kg body weight by IV infusion
- DrugPosaconazole PFS 6 mg/kg
POS nominal 6 mg/kg body weight based on weight bands taken orally
Locations (26)
- Rady Children's Hospital-San Diego ( Site 2101)San Diego, California
- Nicklaus Children's Hospital ( Site 2109)Miami, Florida
- Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)Chicago, Illinois
- Duke University Medical Center ( Site 2106)Durham, North Carolina
- Driscoll Children's Hospital ( Site 2113)Corpus Christi, Texas
- UCL Saint Luc ( Site 1050)Brussels, Bruxelles-Capitale, Region de