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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
POS 6 mg/kg body weight by IV infusion
POS 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.
Time frame: Predose, 0.25 and 24 hours post-infusion on Day 1
Maximum concentration (Cmax) of single-dose IV POS (Panel A)
The Cmax of IV POS is based on population PK analysis.
Time frame: Predose, 0.25 and 24 hours post-infusion on Day 1
Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)
The Tmax of IV POS is based on population PK analysis.
Time frame: Predose, 0.25 and 24 hours post-infusion on Day 1
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.
Time frame: Predose, 0.25 and 24 hours post-infusion on Day 1
Clearance (CL) of single-dose IV POS (Panel A)
The clearance (CL) of IV POS is based on population PK analysis.
Time frame: Predose, 0.25 and 24 hours post-infusion on Day 1
Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A)
The AUC0-∞ of IV POS is based on population PK analysis.
Time frame: Predose, 0.25 and 24 hours post-infusion on Day 1
Cavg of multiple-dose IV POS (Panel B)
The Cavg of IV POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rady Children's Hospital-San Diego ( Site 2101)
San Diego, California, United States
COMPLETEDNicklaus Children's Hospital ( Site 2109)
Miami, Florida, United States
COMPLETEDAnn & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago, Illinois, United States
RECRUITINGDuke University Medical Center ( Site 2106)
Durham, North Carolina, United States
COMPLETEDDriscoll Children's Hospital ( Site 2113)
Corpus Christi, Texas, United States
COMPLETEDUCL Saint Luc ( Site 1050)
Brussels, Bruxelles-Capitale, Region de, Belgium
RECRUITINGUZ Gent ( Site 1052)
Ghent, Oost-Vlaanderen, Belgium
RECRUITINGUZ Leuven ( Site 1051)
Leuven, Vlaams-Brabant, Belgium
RECRUITINGAthens Childrens Hospital Aglaia Kyriakou ( Site 1102)
Athens, Attica, Greece
COMPLETEDGeneral Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
Thessaloniki, Greece
RECRUITING...and 16 more locations
Cmax of multiple-dose IV POS (Panel B)
The Cmax of IV POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Tmax of multiple-dose IV POS (Panel B)
The Tmax of IV POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
AUC0-24 of multiple-dose IV POS (Panel B)
The AUC0-24 of IV POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
CL of multiple-dose IV POS (Panel B)
The CL of IV POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Cavg of multiple-dose PFS POS (Panel B)
The Cavg of PFS POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Cmax of multiple-dose PFS POS (Panel B)
The Cmax of PFS POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
AUC0-24 of multiple-dose PFSPOS (Panel B)
The AUC0-24 of PFS POS is based on population PK analysis.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
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.
Time frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
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.
Time frame: Up to 98 days
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.
Time frame: Up to 84 days
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.
Time frame: Up to 98 days
Percentage of participants with all-cause mortality (ACM) [Panel B]
The percentage of participants with ACM will be reported.
Time frame: Up to 28 days
Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period (Panel B)
Percentage of participants who received additional antifungal therapy in Panel B will be reported.
Time frame: Up to 84 days