Conditions: Healthy Volunteer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: yes

Brief summary:
This study is an open-label, multi-center, single-dose, parallel group study to determine the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted male and female adult subjects with varying degrees of hepatic function. The study will be conducted based on the Child-Pugh classification of hepatic impairment. The anticipated duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying degrees of hepatic function and up to 12 healthy control volunteers.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: cobimetinib
Intervention descriptions: intervention 1: single oral 10-mg dose of cobimetinib

Protocol document: