Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Pharmacokinetic Profile
研究概览
简要总结
A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.
详细描述
This study is designed to assess the mass balance of [14C]linifanib and the metabolic profiles of linifanib in 4 subjects with advanced solid tumors following a single oral dose. Subjects may continue on linifanib after completion of the metabolism study. The results of this study will determine the exposure of major metabolites and excretion pathway(s) of the parent drug and metabolites of linifanib in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ADME
[14C]linifanib
干预措施: [14C]linifanib (Drug)
Extension
linifanib
干预措施: ABT-869, linifanib (Drug)
结局指标
主要结局
Pharmacokinetic Profile
时间窗: Various timepoints from Day 1 through approximately Day 9
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.
Total radioactivity
时间窗: Various timepoints from Day 1 through approximately Day 9
Blood, urine, and fecal samples for total radioactivity analysis will be collected at designated time points.
次要结局
- Safety (Number of subjects with adverse events and/or dose-limiting toxicities)(At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment))