An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Bosutinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Inclusion criteria (for both study populations):
1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at
WONCBP may be included if they are either surgically sterile (hysterectomy and/or
oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating
hormone [FSH] level greater than or equal to 8 mIU/mL) and must have a negative serum
pregnancy test result within 48 hours before administration of test article. Women
who are surgically sterile must provide documentation of the procedure by an
operative report or by ultrasound scan. Sexually active men must agree to use a
medically acceptable form of contraception during the study and continue using it for
12 weeks after test article administration.
2. Have a high probability for compliance with and completion of the study.
Exclusion criteria (for both study populations):
1. History of clinically important cardiovascular disease.
2. Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related
3. Presence or history of any disorder that may prevent the successful completion of the
Other inclusion and exclusion criteria apply.