A Phase 2 interventional study of Posaconazole IV 6 mg/kg and Posaconazole PFS 6 mg/kg in Invasive Fungal Infection, sponsored by Merck Sharp & Dohme LLC. Recruiting at 26 sites in 10 countries. Open to participants aged 1 Day to 2 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
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.
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 67 interventional studies indexed under Invasive Fungal Infections.
Browse Invasive Fungal Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1.
Drug: Posaconazole IV 6 mg/kg
Posaconazole 6 mg/kg body weight administered twice daily by IV infusion on Day 1, and then once daily from Day 2 to a maximum 84 days.
Drug: Posaconazole IV 6 mg/kg
Following a minimum of 7 days IV dosing, participants as clinically able will be transitioned from POS IV to POS PFS nominal 6 mg/kg body weight based on weight bands administered on Day 8, once daily to a maximum 84 days.
Drug: Posaconazole PFS 6 mg/kg
Drug page: Posaconazole
POS 6 mg/kg body weight by IV infusion
Also known as: MK-5592, NOXAFIL®, SCH56592
Drug page: Posaconazole
POS nominal 6 mg/kg body weight based on weight bands taken orally
Also known as: MK-5592, NOXAFIL®, SCH56592
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
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
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Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
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Studies of the drug tested here: Posaconazole