A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 74 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | January 2015 |
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.
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.
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
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