JAPIC ID: JapicCTI-111577
Registered date:
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
Basic Information
Recruitment status | |
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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 |
Countries of recruitment | |
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 ] |
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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 |
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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. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Refer to the information of contact(s) |
Contact
public contact | |
Name | Pfizer Inc. Pfizer CT.gov Call Center |
Address | clinical-trials@pfizer.com |
Telephone | |
Affiliation | |
scientific contact | |
Name | Pfizer Inc. Pfizer CT.gov Call Center |
Address | clinical-trials@pfizer.com |
Telephone | |
Affiliation |