An Open-label, Single-center Study to Assess the Pharmacokinetics of R406 in Subjects With Hepatic Impairment and in Healthy Subjects Following Administration of a Single Dose of Fostamatinib Disodium 150 mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To determine plasma PK parameters of R406 in subjects with varying degrees of hepatic impairment as well as in healthy subjects (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2))
研究概览
简要总结
A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. The study will also evaluate safety and tolerability in subjects with hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females (non child-bearing potential) aged 18 years or more, with a weight of at least 50 kg and body mass index (BMI) between 18 and 40 kg/m2 inclusive
- •Healthy subjects only: good health as determined by a medical history, physical examination , ECG and clinical laboratory evaluations
- •Healthy subjects only: negative results for serum hepatitis B and C
排除标准
- •Subjects who have received any medications known to alter drug absorption or elimination within 30 days of first dose.
- •Subjects who smoke more than 10 cigarettes or equivalent per day
- •Absolute neutrophil count <2500/mm3
- •Abnormal vital signs, additional systemic disease (eg, cardiac, or renal disease) or abnormal laboratory findings that are judged to be clinically significant by the investigator
- •Healthy volunteers only: use of prescribed medications within 2 weeks of first dose or use of non-prescribed medications within 1 week of first dose
- •Hepatic subjects only: fluctuating or rapidly deteriorating hepatic function
研究组 & 干预措施
1
Mild hepatic impairment
干预措施: Fostamatinib (Drug)
2
Moderate hepatic impairment
干预措施: Fostamatinib (Drug)
3
Severe hepatic impairment
干预措施: Fostamatinib (Drug)
4
Matched healthy volunteers with normal hepatic function
干预措施: Fostamatinib (Drug)
结局指标
主要结局
To determine plasma PK parameters of R406 in subjects with varying degrees of hepatic impairment as well as in healthy subjects (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2))
时间窗: From pre-dose until 120 hours after the single dose
次要结局
- To investigate safety and tolerability of fostamatinib 150mg: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.(From pre-dose until 120 hours after the single dose)