NCT00550212已完成1 期
An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled HKI-272 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Mass balance, metabolic distribution, PK
研究概览
简要总结
The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, aged 18 to 50 years.
排除标准
- •Female subjects
研究组 & 干预措施
1
Experimental
240 mg
干预措施: neratinib (Drug)
结局指标
主要结局
Mass balance, metabolic distribution, PK
时间窗: 10 days
次要结局
未报告次要终点
研究者
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