Posaconazole IV 6 mg/kg: POS 6 mg/kg body weight by IV infusion
Posaconazole PFS 6 mg/kg: POS nominal 6 mg/kg body weight based on weight bands taken orally
Study 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).
Eligibility
Sex
ALL
Min age
1 Day
Max age
2 Years
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.
* Has a body weight of ≥500 g
* The participant (or legally acceptable representative) has provided documented informed consent for the study.
Exclusion Criteria
* 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
* Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used
* Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention
* Has received any listed prohibited medications within the specified timeframes before the start of study intervention
* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Part B)
* Has suspected/proven invasive candidiasis (Part B)
* Has enrolled previously in the current study and been discontinued
* Has QTc prolongation at screening \>500 msec
* Has significant liver dysfunction
* Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
Primary outcome measure(s)
Average concentration (Cavg) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1 The Cavg of IV POS is based on population PK analysis.
Maximum concentration (Cmax) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1 The Cmax of IV POS is based on population PK analysis.
Time to maximum concentration (Tmax) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1 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) — Predose, 0.25 and 24 hours post-infusion on Day 1 The AUC 0-24 of IV POS is based on population PK analysis.
Clearance (CL) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1 The clearance (CL) of IV POS is based on population PK analysis.
Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A) — Predose, 0.25 and 24 hours post-infusion on Day 1 The AUC0-∞ of IV POS is based on population PK analysis.
Cavg of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The Cavg of IV POS is based on population PK analysis.
Cmax of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The Cmax of IV POS is based on population PK analysis.
Tmax of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The Tmax of IV POS is based on population PK analysis.
AUC0-24 of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The AUC0-24 of IV POS is based on population PK analysis.
CL of multiple-dose IV POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The CL of IV POS is based on population PK analysis.
Cavg of multiple-dose PFS POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The Cavg of PFS POS is based on population PK analysis.
Cmax of multiple-dose PFS POS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The Cmax of PFS POS is based on population PK analysis.
AUC0-24 of multiple-dose PFSPOS (Panel B) — Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 The AUC0-24 of PFS POS is based on population PK analysis.
Trial sites (26)
Facility
City
Region
Status
Rady Children's Hospital-San Diego ( Site 2101)
San Diego
California
Completed
Nicklaus Children's Hospital ( Site 2109)
Miami
Florida
Completed
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago
Illinois
Recruiting
Duke University Medical Center ( Site 2106)
Durham
North Carolina
Completed
Driscoll Children's Hospital ( Site 2113)
Corpus Christi
Texas
Completed
UCL Saint Luc ( Site 1050)
Brussels
Bruxelles-Capitale, Region de
Recruiting
UZ Gent ( Site 1052)
Ghent
Oost-Vlaanderen
Recruiting
UZ Leuven ( Site 1051)
Leuven
Vlaams-Brabant
Recruiting
Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
Athens
Attica
Completed
General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
Thessaloniki
Greece
Recruiting
Rambam Medical Center ( Site 1402)
Haifa
Israel
Recruiting
Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
Jerusalem
Israel
Completed
Sheba Medical Center ( Site 1404)
Ramat Gan
Israel
Recruiting
Sourasky Medical Center ( Site 1403)
Tel Aviv
Israel
Recruiting
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
Mexico City
Mexico City
Recruiting
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
Mexico City
Mexico City
Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)
Monterrey
Nuevo León
Recruiting
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
Lima
Peru
Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)
Wroclaw
Lower Silesian Voivodeship
Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
Olsztyn
Warmian-Masurian Voivodeship
Completed
Mechnikov State Medical University ( Site 1803)
Saint Petersburg
Sankt-Peterburg
Completed
Pavlov State Medical University ( Site 1801)
Saint Petersburg
Sankt-Peterburg
Completed
Regional Children Clinical Hospital 1 ( Site 1802)
Yekaterinburg
Sverdlovsk Oblast
Completed
Seoul National University Hospital-Pediatrics ( Site 2600)
Seoul
South Korea
Recruiting
Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
Ivano-Frankivsk
Ivano-Frankivsk Oblast
Recruiting
NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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