NCT01197781已完成1 期
An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers When Fostamatinib Disodium 150 mg is Administered Alone and in Combination With Verapamil
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 determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.
研究概览
简要总结
This Study evaluates the possible drug interaction between FosD and verapamil when taken together.
详细描述
An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with Verapamil.
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
- •Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive.
- •Females must be of non-childbearing potential
排除标准
- •History of clinically significant disease or disorder or presence of GI, hepatic or renal disease
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the drug
- •Any clinically significant abnormalities in lab safety tests or vital signs as results as judged by the Investigator
- •Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
- •Current smokers or use of nicotine products within 1 month prior to enrollment
研究组 & 干预措施
Period 1
Experimental
干预措施: FOSTAMATIN (Drug)
Period 2
Experimental
干预措施: FOSTAMATIN (Drug)
Period 2
Experimental
干预措施: Verapamil (Drug)
结局指标
主要结局
To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.
时间窗: Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD
次要结局
- To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.(Screening, throughout both treatment periods, and follow-up.)
研究者
研究点 (1)
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