NCT01019070已完成1 期
Multiple-Dose Pharmacokinetics of BMS-650032 in Subjects With Hepatic Impairment Compared to Healthy Subjects
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI
研究概览
简要总结
The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 18 to 70, with hepatic impairment conforming to Child-Pugh class A,B or C
- •Each matched control subjects determined to be healthy
排除标准
- •History of esophageal and gastric bleeding within the past 6 months
- •Primarily cholestatic liver disease
- •Active alcoholic hepatitis
- •Stable encephalopathy of ≥Stage 2
- •Presence of severe ascites or edema
- •Presence of hepatopulmonary or hepatorenal syndrome
- •Positive for HIV
- •Positive for HCV, unless HCV RNA is undetectable
研究组 & 干预措施
BMS-650032 in Child-Pugh A
Active Comparator
干预措施: BMS-650032 (Drug)
BMS-650032 in Child-Pugh B
Active Comparator
干预措施: BMS-650032 (Drug)
BMS-650032 in Child-Pugh C
Active Comparator
干预措施: BMS-650032 (Drug)
BMS-650032 in Healthy Subjects
Active Comparator
干预措施: BMS-650032 (Drug)
结局指标
主要结局
Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI
时间窗: Day 10
次要结局
- Assess the safety and tolerability of BMS-650032 in subjects with hepatic impairment and in healthy subjects. This will be measured by: blood chemistries, hematology, urinalysis and ECGs(Day 10)
- Assess the relationship between the Child-Pugh classification (including its components) and BMS-650032 PK parameters. This will be measured by frequent pharmacokinetics blood samples.(Day 10)
研究者
研究点 (2)
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