An Open-label, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg 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
- To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation)
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
- •Provision of signed and dated informed consent prior to any study specific procedures
- •Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
- •Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- •Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
研究组 & 干预措施
A
Fostamatinib 50 mg tablet x 2 (Phase 3 batch)
干预措施: Fostamatinib (Drug)
B
Fostamatinib 50 mg tablet x 3 (Phase 3 batch)
干预措施: Fostamatinib (Drug)
C
Fostamatinib 100 mg tablet (new formulation)
干预措施: Fostamatinib (Drug)
D
Fostamatinib 150 mg tablet (new formulation)
干预措施: Fostamatinib (Drug)
E
Fostamatinib 50 mg tablet x 2 (Phase 3 batch)
干预措施: Fostamatinib (Drug)
结局指标
主要结局
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation)
时间窗: From Pre-dose until 96 hours post dose of each treatment period
Assessments will include but is not limited to: plasma R406 AUC, Cmax
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation)
时间窗: From pre-dose until 96 hours post dose of each treatment period
Assessments will include but is not limited to: plasma R406 AUC, Cmax )
次要结局
- To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches(From pre-dose until 96 hours post dose of each treatment period)
- To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.(From pre-dose until 96 hours post dose of each treatment period)