Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection

JAPIC ID: JapicCTI-111577

Registered date:

Basic Information

• Health condition(s) or Problem(s) studied: *Aspergillosis, Aspergilloma *Candidemia, Candidiasis *Cryptococcal Meningitis, Pulmonary Cryptococcosis *Fusariosis *Scedosporiosis
• Date of first enrollment: 20/9/2011
• Target sample size: 20
• Study type: INTERVENTIONAL

Intervention(s)

Intervention name : Voriconazole
INN of the intervention : Voriconazole
Dosage And administration of the intervention : *Children aged 2 to <12 yrs and 12 to <15 yrs weighing <50 kg:Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h *Children aged 12 to <15 years weighing more than 50 kg:Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h.
Control intervention name : null

Outcome(s)

Primary Outcome

- Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration AUC12,ss = Area under the
plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. [ Time Frame: Day 7 (up to Day 20 or
more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ]
- Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at
predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ]
- Time to Reach Cmax (Tmax) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162
minutes, 4, 6, 8 and 12 hours postdose ]
- AUC12,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdos ]
- Cmax,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdos ]
- Tmax Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

Secondary Outcome

- Ratio of AUC12,ss Following IV Administration and AUC12,ss Following Oral Administration [ Time Frame: Day 7 (up to Day 20 or
more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ]
- AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or
more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ]
- Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more)
at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ]
- Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at
predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ]
- AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose,
1, 2, 4, 6, 8 and 12 hours postdose ]
- Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1,
2, 4, 6, 8 and 12 hours postdose ]
- Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2,
4, 6, 8 and 12 hours postdose ]

Key inclusion & exclusion criteria

• Age minimum: 2
• Age maximum: 15
• Gender: BOTH

Include criteria

- Male or female from 2 to <15 years of age.
- Require treatment for the prevention of systemic fungal infection.
- Expected to develop neutropenia (ANC <500 cells/uL) lasting more than 10 days following chemotherapy.

Exclude criteria

- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia,
hypokalemia, hypomagnesemia or hypocalcemia.
- Documented bacterial or viral infection not responding to appropriate treatment.
- Hypersensitivity to or severe intolerance of azole antifungal agents.
- Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.

Related Information

• Primary Sponsor: Pfizer Japan Inc.
• Source(s) of Monetary Support: Refer to the information of contact(s)