NCT01355354已完成1 期
An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily
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
- 21
- 试验地点
- 1
- 主要终点
- To investigate whether the plasma concentration-time profiles and resulting PK parameters of digoxin are altered during steady-state fostamatinib administration. Digoxin AUCss and Cmaxss 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 digoxin by comparing the safety, tolerability and plasma concentration of digoxin when administered alone and with fostamatinib in healthy subjects.
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 45 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
- •Male or female subjects aged 18 to 45 years (inclusive)
- •Minimum weight of 50 kg and body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
- •Female subjects must have a negative pregnancy test at screening and on Day -1,must not be lactating, and must be of non-childbearing potential
排除标准
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the 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 the investigational product
- •Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- •Absolute neutrophil count of <2500/mm3 or 2.5 x 109/L
- •Previous treatment with fostamatinib or digoxin in the present study
研究组 & 干预措施
1
Experimental
Digoxin
干预措施: Digoxin (Drug)
2
Experimental
Fostamatinib
干预措施: Digoxin (Drug)
2
Experimental
Fostamatinib
干预措施: Fostamatinib (Drug)
结局指标
主要结局
To investigate whether the plasma concentration-time profiles and resulting PK parameters of digoxin are altered during steady-state fostamatinib administration. Digoxin AUCss and Cmaxss will be measured
时间窗: Day 8 and Day 15
次要结局
- To examine the safety + tolerability of fostamatinib in combination with digoxin. Assessments: Adverse events, lab assessments, vital signs, phys exam,12-lead ECG. Absolute values and change in baseline for any of these parameters will be reported(From screening, Day 1 - Day 17, through to Follow up visit)
- To examine the steady-state PK of R406 during co-administration of fostamatinib with digoxin at steady-state. R406 AUCss, tmaxss and Cmaxss will be measured(Day 15)
- To examine the urinary steady-state PK of digoxin in healthy subjects when administered alone and in combination with fostamatinib at steady-state. Digoxin Ae(0-t), Fe, and CLr will be measured(Day 8 and Day 15)
研究者
研究点 (1)
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