NCT00829231已完成1 期
Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)
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
- Bayer
- 入组人数
- 45
- 主要终点
- PK measurements
研究概览
简要总结
This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Arm 2
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Arm 3
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
PK measurements
时间窗: Day 1-6
次要结局
- Vital Signs(Screening Day 1, Day 6)
- Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis(Screening Day 1, Day 6)
- Physical Exam(Screening, Day 6)
- ECG(Screening Day 1, Day 6)
- Follow up phone call(Day 14)
研究者
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