An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
研究概览
简要总结
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Weight of at least 50 kg and body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
- •Volunteers must be willing to use barrier contraception ie, condoms, from the Day 1 of Treatment Period 1 until 2 weeks after the final dosing of the investigational product (IP)
排除标准
- •History of any clinically significant disease or disorder
- •History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
- •Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
- •Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator
研究组 & 干预措施
1
Fostamatinib 50 mg tablet x 2
干预措施: Fostamatinib (Drug)
2
Fostamatinib 100 mg tablet (batch 1)
干预措施: Fostamatinib (Drug)
3
Fostamatinib 100 mg tablet (batch 2)
干预措施: Fostamatinib (Drug)
4
Fostamatinib 100 mg tablet (batch 4)
干预措施: Fostamatinib (Drug)
结局指标
主要结局
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
时间窗: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
时间窗: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
次要结局
- To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.(Screening, throughout the 4 treatment periods, and follow-up)