NCT04665037 · Merck Sharp & Dohme LLC
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
What this study is about
This study aims to estimate the how the drug moves through the body (PK) of posaconazole (POS, MK-5592) given through a vein (IV) (IV) and powder for taken by mouth suspension (PFS) formulations in pediatric participants \<2 years of age with invasive fungal infection (IFI).
View original scientific description
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).
Interventions
DRUG
Posaconazole IV 6 mg/kg
POS 6 mg/kg body weight by IV infusion
DRUG
Posaconazole PFS 6 mg/kg
POS nominal 6 mg/kg body weight based on weight bands taken orally
Primary outcome measures
Average concentration (Cavg) of single-dose IV POS (Panel A)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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,
Where
- San Diego, California
- Miami, Florida
- Chicago, Illinois
- Durham, North Carolina
- Corpus Christi, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2025 · Source of record for eligibility and locations