An Open-label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir in the Treatment of Infants Less Than One Year of Age With Influenza Infection
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
研究概览
简要总结
This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days. Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant patients
- •Date of birth to date of enrollment is <1 year
- •Diagnosis of influenza
- •Duration of influenza symptoms </=96 hours prior to first dose
- •- Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)
排除标准
- •Date of conception to date of birth + date of birth to enrollment is <36 weeks
- •Creatinine clearance <30 mL/min/1.73m2
- •Patients receiving any form of renal replacement therapy at baseline
- •Clinical evidence of severe hepatic decompensation at the time of enrollment
- •Patients taking probenecid medication within 1 week prior to study day 1 or during the study
研究组 & 干预措施
1
干预措施: Tamiflu (Drug)
结局指标
主要结局
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
时间窗: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2
AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4
时间窗: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4
时间窗: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1
时间窗: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1
Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1
时间窗: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1
Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2
时间窗: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2
次要结局
- Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate(Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4)
- Number of Participants With Oseltamivir Resistance Mutation(Up to Day 30)
- Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate(Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4)
- Number of Participants With Greater Than or Equal to (≥) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values(Baseline, Days 1, 3, 4, 6, 15)
- Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate(Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4)