An Open Label, Single-dose, Multi-center, Parallel-group, Two-staged Study to Evaluate Pharmacokinetics of Oral cMET Inhibitor INC280 in Non-Cancer Subjects With Impaired Hepatic Function and Non-Cancer Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 5
- 主要终点
- AUClast of INC280
研究概览
简要总结
This is a phase I, multi-center, open-label, single oral dose, parallel group study to evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired hepatic function and non-cancer subjects with normal hepatic function.The study population will be healthy male and postmenopausal or sterile female subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will be assigned to groups according to their hepatic function: normal (Group 1), mild (Group 2), moderate (Group 3), and severe (Group 4) impairment. This study consists of a two-staged design with interim analysis. In Stage 1, subjects in Groups 1, 2 and 3 will be enrolled. Upon completion of Stage 1, an interim analysis will be conducted. Depending on the results of the analysis, either the study will conclude with no further enrollment or Stage 2 will commence with enrollment of Group 4.
A minimum of 6 evaluable subjects per group will be enrolled.Once enrolled in the study, participants will be confined to the facility for 4 days, given a single dose of INC280 and monitored for pharmacokinetic and safety assessments.
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 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
- 未提供
研究组 & 干预措施
Normal hepatic function
Subjects with normal hepatic function
干预措施: INC280 (Drug)
Mild hepatic impairment
Subjects with mild hepatic impairment
干预措施: INC280 (Drug)
Moderate hepatic impairment
Subjects with moderate hepatic impairment
干预措施: INC280 (Drug)
Severe hepatic impairment
Subjects with severe hepatic impairment
干预措施: INC280 (Drug)
结局指标
主要结局
AUClast of INC280
时间窗: Up to 72 hours post-dose
INC280 pharmacokinetic parameters
AUCinf of INC280
时间窗: Up to 72 hours post-dose
INC280 pharmacokinetic parameters
CL/F of INC280
时间窗: Up to 72 hours post-dose
INC280 pharmacokinetic parameters
Vz/F of INC280
时间窗: Up to 72 hours post-dose
INC280 pharmacokinetic parameters
Cmax of INC280
时间窗: Up to 72 hours post-dose
INC280 pharmacokinetic parameters
Tmax of INC280
时间窗: Up to 72 hours post-dose
INC280 pharmacokinetic parameters
T1/2 of INC280
时间窗: Up to 72 hours post-dose
INC280 pharmacokinetic parameters
次要结局
- Unbound fraction and T1/2 based on unbound concentration in plasma(3 hours post-dose)
- Unbound fraction and CL/F based on unbound concentration in plasma(3 hours post-dose)
- Unbound fraction and Vz/F based on unbound concentration in plasma(3 hours post-dose)
- Adverse events based on the CTCAE v4.03 grade (severity) and frequency, and other safety data (e.g., ECG, laboratory results)(Up to 30 days)
- Unbound fraction and AUClast based on unbound concentration in plasma(3 hours post-dose)
- Unbound fraction and AUCinf based on unbound concentration in plasma(3 hours post-dose)
- Unbound fraction and Cmax based on unbound concentration in plasma(3 hours post-dose)
- Unbound fraction and Tmax based on unbound concentration in plasma(3 hours post-dose)
