A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDK378 in Subjects With Hepatic Impairment Compared to Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- LDK378 pharmacokinetic parameters (T1/2)
研究概览
简要总结
Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 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
- 未提供
研究组 & 干预措施
Mild Hepatic Impairment
Subjects with mild hepatic impairment
干预措施: LDK378 (Drug)
Moderate Hepatic Impairment
Subjects with moderate hepatic impairment
干预措施: LDK378 (Drug)
Normal Hepatic Function
Subjects with normal hepatic function
干预措施: LDK378 (Drug)
Severe Hepatic Impairment
Subjects with severe hepatic impairment
干预措施: LDK378 (Drug)
结局指标
主要结局
LDK378 pharmacokinetic parameters (T1/2)
时间窗: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (Vz/F)
时间窗: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters ( Cmax)
时间窗: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (Tmax)
时间窗: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (AUCinf)
时间窗: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters ( AUClast)
时间窗: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (CL/F)
时间窗: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
次要结局
- Number of subjects with Adverse events(after informed consent is signed, 30 days after last dose)
- Plasma protein binding of LDK378(Day 1 predose, Day 1 6 hours postdose)