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

NCT ID: NCT02300025

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-01-31

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Cohort 1: Normal function

Group Type: EXPERIMENTAL

cobimetinib

Intervention Type: DRUG

single oral 10-mg dose of cobimetinib

Cohort 2: Mild Hepatic Impairment

Group Type: EXPERIMENTAL

cobimetinib

Intervention Type: DRUG

single oral 10-mg dose of cobimetinib

Cohort 3: Moderate Hepatic Impairment

Group Type: EXPERIMENTAL

cobimetinib

Intervention Type: DRUG

single oral 10-mg dose of cobimetinib

Cohort 4: Severe Hepatic Impairment

Group Type: EXPERIMENTAL

cobimetinib

Intervention Type: DRUG

single oral 10-mg dose of cobimetinib

Interventions

cobimetinib

single oral 10-mg dose of cobimetinib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Anaheim, California, United States

Miami, Florida, United States

Orlando, Florida, United States

Countries

United States

Other Identifiers

GP29342

Identifier Type: -

Identifier Source: org_study_id