A Phase I, Open-label, Multi-center, Single-dose Study to Evaluate the Pharmacokinetics of ABL001 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Primary Pharmacokinetics (PK): AUClast
研究概览
简要总结
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome
- •History of cardiac disease
- •Sexually active males must use a condom during intercourse while taking the drug and for 7 days after stopping
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
- •Administration of strong or moderate CYP3A4 inhibitors or inducers (including St John's wort) within 14 days prior to dosing
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
ABL001
干预措施: ABL001 (Drug)
结局指标
主要结局
Primary Pharmacokinetics (PK): AUClast
时间窗: at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): T 1/2
时间窗: at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): CL/F
时间窗: at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Primary Pharmacokinetics (PK): Cmax
时间窗: at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Primary Pharmacokinetics (PK): AUCinf
时间窗: at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): Tmax
时间窗: at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): Vz/F
时间窗: at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
次要结局
- ABL001 pharmacokinetic parameter - Cmax - based on unbound fraction in plasma(2 hours post-dose)
- ABL001 pharmacokinetic parameter - AUClast - based on unbound fraction in plasma(2 hours post-dose)
- ABL001 pharmacokinetic parameter - AUCinf - based on unbound fraction in plasma(2 hours post-dose)
- Percentage of plasma protein binding as expressed by unbound fraction in plasma(2 hours post-dose)