A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 12
- 主要终点
- Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
研究概览
简要总结
This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History or laboratory evidence of herpes simplex infection
- •Clinical evidence or suspicion of herpes simplex infection
排除标准
- •Patients unable to swallow
- •Concomitant use of probenecid
- •Positive pregnancy test
- •Additional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228
研究组 & 干预措施
Famciclovir, pediatric oral formulation
single-arm
干预措施: Famciclovir (Drug)
结局指标
主要结局
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
时间窗: 8 hours and 24 hours after study drug administration (Part A)
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Maximum Observed Plasma Concentration of Penciclovir (Cmax)
时间窗: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
PK parameter; penciclovir is the active metabolite of famciclovir.
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
时间窗: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
PK parameter; penciclovir is the active metabolite of famciclovir.
Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
时间窗: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
PK parameter; penciclovir is the active metabolite of famciclovir.
Apparent Oral Clearance of Penciclovir (CL/F)
时间窗: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
PK parameter; penciclovir is the active metabolite of famciclovir.
Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
时间窗: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
PK parameter; penciclovir is the active metabolite of famciclovir
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
时间窗: Administered 2 times daily over 7 days
A patient with multiple AEs within the primary system organ class is counted only once in total row.
次要结局
- Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.(Day 1, after swallowing the dose.)
- Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.(Day 1 at clinic: after swallowing first dose)
- Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study(Day 8 at home: after swallowing last dose)