Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir
研究概览
简要总结
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented chronic hepatitis C (CHC) genotype 1 infection
- •Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
- •Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
- •Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
- •Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study
排除标准
- •Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
- •Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
- •Discontinued from interferon treatment due to adverse events
- •Currently receiving antiviral/immunomodulating therapy for hepatitis C
- •Prior treatment with an HCV protease inhibitor
- •Prior treatment with any known hepatotoxic agent (including herbal remedies)
- •Use of investigational drugs within 30 days of enrollment into study
- •Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
- •Substance abuse (including but not limited to alcohol abuse, illicit drugs,
- •inhalational drugs, marijuana use, etc) any time prior to entry into the study
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- •Pregnant or breastfeeding female
- •Meeting any of the laboratory exclusion criteria
研究组 & 干预措施
Cohort 1: Children 17 to ≥13 years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
干预措施: Boceprevir (Drug)
Cohort 2: Children <13 to ≥7 years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
干预措施: Boceprevir (Drug)
Cohort 3: Children <7 to ≥3 years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
干预措施: Boceprevir (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir
时间窗: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.
Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir
时间窗: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
The maximum observed plasma concentration of boceprevir across sampling intervals was determined.
Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir
时间窗: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
The time at which the maximum plasma boceprevir concentration was observed.
Final Dose of Boceprevir By Age Group
时间窗: Day 1
次要结局
未报告次要终点