NCT01336218已完成1 期
An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin
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
- AstraZeneca
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured
研究概览
简要总结
The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Males or females aged 18 to 55 years (inclusive)
- •Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
- •Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential
排除标准
- •History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
- •Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
- •Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- •Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- •Any previous treatment with fostamatinib
研究组 & 干预措施
1
Experimental
Fostamatinib
干预措施: fostamatinib (Drug)
2
Experimental
Rifampicin
干预措施: fostamatinib (Drug)
2
Experimental
Rifampicin
干预措施: rifampicin (Drug)
结局指标
主要结局
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured
时间窗: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
次要结局
- To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured(Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose)
- To examine the safety and tolerability of fostamatinib in combination with rifampicin.(From screening, Day 1 - Day 25, up to follow up visit)
研究者
研究点 (1)
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