NCT00759837已完成1 期
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Bosutinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 27 人开始时间: 2008年10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
- 27
- 主要终点
- Blood samples
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Bosutinib (Drug)
结局指标
主要结局
Blood samples
时间窗: 5 weeks
次要结局
- Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.(5 weeks)
研究者
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2 期
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进行中（未招募）
不适用
A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.Solid tumor and ErbB2 negative locally advanced or metastatic breast cancerMedDRA version: 12.0Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2009-011878-15-HUWyeth Research Division of Wyeth Pharmaceuticals Inc152
进行中（未招募）
1 期
A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.EUCTR2009-011878-15-BEWyeth Research Division of Wyeth Pharmaceuticals Inc152
进行中（未招募）
1 期
A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.Solid tumor and ErbB2 negative locally advanced or metastatic breast cancerMedDRA version: 12.0Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2009-011878-15-FRWyeth Research Division of Wyeth Pharmaceuticals Inc152