An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To <12 Years Who Are At High Risk For Systemic Fungal Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
研究概览
简要总结
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female from 2 to <12 years of age.
- •Require treatment for the prevention of systemic fungal infection.
- •Expected to develop neutropenia (ANC <500 cells/μL) lasting more than 10 days following chemotherapy.
- •Anticipated to live for more than 3 months.
排除标准
- •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.
研究组 & 干预措施
Children aged 2 to <12 years
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection.
干预措施: voriconazole (Vfend) (Drug)
结局指标
主要结局
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
时间窗: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
时间窗: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Time to Reach Cmax (Tmax) Following IV Administration
时间窗: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
AUC12,ss Following Oral Administration
时间窗: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Cmax,ss Following Oral Administration
时间窗: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Tmax Following Oral Administration
时间窗: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
次要结局
- AUC12 Following IV Loading Dose(Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose)
- Cmax Following an IV Loading Dose(Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose)
- Tmax Following an IV Loading Dose(Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose)
- Trough Concentrations (Cmin)(Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose)
- AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration(Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose)
- Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration(Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose)
- Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration(Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose)
- AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration(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(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(Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose)