Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

Conditions

• Invasive Fungal Infection

Eligibility Criteria

Sex

ALL

Age

1 Day - 2 Years

Healthy Volunteers

Not accepted

Interventions

• Posaconazole IV 6 mg/kg — DRUG
  POS 6 mg/kg body weight by IV infusion
• Posaconazole PFS 6 mg/kg — DRUG
  POS nominal 6 mg/kg body weight based on weight bands taken orally

Study Details

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).

Key Dates

Start date

Feb 22, 2022

Status verified

Sep 2025

Primary completion

Dec 16, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (5)

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