Recruiting
Phase 2

Posaconazole

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT04665037

Conditions

Invasive Fungal Infection

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Posaconazole IV 6 mg/kg

Posaconazole PFS 6 mg/kg

Study Details

Brief 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).

Conditions

Invasive Fungal Infection

Study ID

NCT04665037

Start date

Feb 22, 2022

Status verified date

Jul, 2026

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Panel A: POS IV

Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1.

experimental: Panel B: POS IV

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.

experimental: Panel B: POS PFS

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.

Interventions

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

Primary outcome measure

  • Average concentration (Cavg) of single-dose IV POS (Panel A) [ Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1 ]
  • Maximum concentration (Cmax) of single-dose IV POS (Panel A) [ 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) [ 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) [ Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1 ]
  • Clearance (CL) of single-dose IV POS (Panel A) [ 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) [ Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Study Coordinator

312-227-6280

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-12.