NCT01002378已完成1 期
A Phase I, Randomized, Open Label, 3-Way Cross-Over Study to Determine the Effect of a High-Fat Breakfast, a Low-Fat Breakfast and Fasting State on the Pharmacokinetics of a Single Oral Dose of 160 mg 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
- Primary PK parameters: AUC, Cmax of BAY 73-4506
研究概览
简要总结
An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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 subject
- •Age: 18 to 45 years (inclusive) at the first Screening examination
- •BMI: between 18 and 32 kg / m²
排除标准
- •Regular use of medicines at the time of Screening, including prescription medications, herbal supplements and high dose vitamins
- •Sitting systolic BP > 140 mmHg or Diastolic BP > 90 or < 60 mmHg
- •History of hypersensitivity or allergy
- •History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
研究组 & 干预措施
Arm 1
Experimental
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
Arm 2
Experimental
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
Arm 3
Experimental
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Primary PK parameters: AUC, Cmax of BAY 73-4506
时间窗: Samples up to 336 hours post dose
次要结局
- Sec. PK Parameters: tmax and t1/2 of BAY73-4506(Samples up to 336 hours post dose)
- AUC, Cmax, tmax and t1/2 of Metabolites(Samples up to 336 hours post dose)
研究者
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