跳至主要内容
临床试验/NCT02474537
NCT02474537已完成1 期

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

Novartis Pharmaceuticals5 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年6月12日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Normal hepatic function

Experimental

Subjects with normal hepatic function

干预措施: INC280 (Drug)

Mild hepatic impairment

Experimental

Subjects with mild hepatic impairment

干预措施: INC280 (Drug)

Moderate hepatic impairment

Experimental

Subjects with moderate hepatic impairment

干预措施: INC280 (Drug)

Severe hepatic impairment

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验