The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
27
Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets)
Pfizer Investigational Site
Moscow, Russia
Plasma concentrations of neratinib in healthy volunteers compared to hepatically impaired patients through analysis of blod samples collected after neratinib administration in these 2 populations.
Time frame: 4 weeks
Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
Time frame: 4 weeks
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