NCT02300025

A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	cobimetinib	single oral 10-mg dose of cobimetinib

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-11-24
• Last updated: 2016-02-19
• Results posted: 2016-02-19

Locations

3 sites across 1 country: United States