INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
Status:
Completed
Trial end date:
2017-09-12
Target enrollment:
Participant gender:
Summary
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.