MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function

Summary

This study is a phase I, multi-center, open-label, single oral dose, parallel group study to assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy subjects with normal hepatic function. Subjects will be assigned by hepatic function defined by elevation of serum total bilirubin and serum AST as determined at the screening and baseline visits. 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. A minimum of 24 evaluable subjects (6 subjects per group) will be enrolled. The groups are: Group 1-healthy volunteers, Group 2-Mild hepatic impairment, Group 3-Moderate hepatic impairment and Group 4-Severe hepatic impairment. Once approved for enrollment, participants will be confined to the facility for 5 days, given a single dose of MEK162 and monitored for safety assessments, labs and PK will be assessed.

Timeline

Start

2014-03

Primary completion

2016-08-01

Completion

2016-08-26

Publications

• Piscitelli J, Hahn E, Wollenberg L, Chavira R, Del Frari L, Reddy MB. Pharmacokinetics of Binimetinib in Participants with Hepatic Impairment. Clin Pharmacokinet. 2025 Aug;64(8):1217-1230. doi: 10.1007/s40262-025-01509-0. Epub 2025 Jun 23.

Drugs

Indications

No indication recorded.