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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: cobimetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02300025

GP29342

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female subjects between 18 and 74 years of age, inclusive
• Body weight >/=45 kg and body mass index between 17 and 41 kg/m2, inclusive
• Subjects with hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening and a stable medication regimen for at least 1 month prior to Check-in
• Agreement to use highly effective contraceptive methods as defined in the protocol

Exclusion criteria

• Significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for subjects with hepatic impairment who due to their liver disease may be affected by significant medical problems which require frequent hospitalizations. Invasive systemic fungal infections need to be fully treated prior to study entry
• Significant history or clinical manifestations of any cardiac event that would put the subject at risk in the opinion of the Investigator
• Use of drugs of abuse within 1 month of Screening or during the entire study
• Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study

Trial design

28 participants in 4 patient groups

Cohort 1: Normal function

Experimental group

Treatment:

Drug: cobimetinib

Cohort 2: Mild Hepatic Impairment

Experimental group

Treatment:

Drug: cobimetinib

Cohort 3: Moderate Hepatic Impairment

Experimental group

Treatment:

Drug: cobimetinib

Cohort 4: Severe Hepatic Impairment

Experimental group

Treatment:

Drug: cobimetinib