An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Adolescents Aged 12 To <17 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
- 26
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
研究概览
简要总结
This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are expected to develop neutropenia following chemotherapy.
- •Subjects who require treatment for the prevention of systemic fungal infection.
排除标准
- •Subjects with a history of severe intolerance of azole antifungal agents.
- •Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.
研究组 & 干预措施
1
干预措施: Voriconazole (Drug)
结局指标
主要结局
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
时间窗: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
Time to Reach Cmax (Tmax) Following IV Administration
时间窗: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
时间窗: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
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.
Tmax Following Oral Administration
时间窗: Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose
AUC12,ss Following Oral Administration
时间窗: Day 7 (up to Day 30) at 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 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
次要结局
- AUC12 Following IV Loading Dose(Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion)
- Cmax Following an IV Loading Dose(Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion)
- Tmax Following an IV Loading Dose(Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion)
- Minimum Observed Plasma Trough Concentration (Cmin)(Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose)
- AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration(Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion)
- Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration(Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion)
- AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration(On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose)
- Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration(Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion)
- Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration(Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose)
- Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration(Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose)