Breast Cancer, Leukemia, Myeloid, Chronic
Conditions
Brief summary
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.
Interventions
DRUGBosutinib
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
(for both study populations): 1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening. 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 death. 3. Presence or history of any disorder that may prevent the successful completion of the study. Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood samples | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. | 5 weeks |
Countries
Poland
Outcome results
None listed