NCT01318265已完成1 期
A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers
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
- 24
- 主要终点
- Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole
研究概览
简要总结
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between 18 and 45 years of age, inclusive
- •BMI between 18 and 32 kg/m2 inclusive
排除标准
- •Subjects with evidence of disease, conditions affecting drug absorption or metabolism
- •Treatment with other investigational drug within 30 days
- •History of regular alcohol or recreational drug consumption
- •Use of prescription drugs within 14 days
- •Use of nonprescription drugs and dietary supplement within 7 days
- •Blood donation within 30 days
研究组 & 干预措施
Arm1
Experimental
干预措施: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole
时间窗: 1 month
Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.
时间窗: 1 month
次要结局
- Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.(1 month)
- Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.(1 month)
- Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.(1 month)
研究者
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