A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 主要终点
- Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac.
研究概览
简要总结
This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.
详细描述
A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female (of non-childbearing potential) Japanese subjects
- •20 to 45 years of age
- •Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg
排除标准
- •History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
- •Any clinically significant illness, acute infection, known inflammatory process, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- •Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
- •Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
- •Previous participation in a fostamatinib study
研究组 & 干预措施
Fostamatinib 100mg
Up to two cohorts of Japanese subjects are planned to receive fostamatinib 100mg single and multiple twice daily doses
干预措施: Fostamatinib 100mg (Drug)
Fostamatinib 200mg
Up to two cohorts of Japanese subjects are planned to receive fostamatinib 200mg single and multiple twice daily doses
干预措施: Fostamatinib 200mg (Drug)
结局指标
主要结局
Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac.
时间窗: PK sampling at predose, 0, 0.25, 0.5, 1,1.5, 2, 4, 6, 8,12, 16, 24, 36, 48 and 72 hours post-dose following the single dose (on Day 1) and after repeated twice daily dosing on Days 4 and 10
AUC - area under the plasma concentration time curve from zero to infinity ; tmax - time to max plasma concentration; t1/2 - terminal elimination half life; Rac - accumulation ratio
次要结局
- Safety and tolerability profile in terms of adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG(Up to Day 20)