Ph I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors.
研究概览
简要总结
This is a phase 1, open-label study designed to determine the interaction of ketoconazole with ABT-869.
详细描述
This study is designed to explore the drug interaction between ketoconazole and ABT-869 to determine the potential effect of ketoconazole on the metabolism of ABT-869. ABT-869 will be taken alone or in combination with ketoconazole. The safety of a single dose administration of ABT-869 when administered alone and in combination with ketoconazole will be assessed.
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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
Arm 1
干预措施: ABT-869 (Drug)
Arm 1
干预措施: ketoconazole (Drug)
结局指标
主要结局
To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors.
时间窗: Different timepoints on Days 1-12
Blood samples for the PK of ABT-869 and ketoconazole will be collected at designated time points throughout the study.
次要结局
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.(Throughout the study)