Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02300025
Start Date
August 1 2014
End Date
January 1 2015
Last Update
February 19 2016
Active Locations (3)
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1
Anaheim, California, United States, 92801
2
Miami, Florida, United States, 330014
3
Orlando, Florida, United States, 32809