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Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

Last updated on February 20, 2019

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Study Location
Warsaw, , 02-507 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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 exclusion criteria apply.

NCT00759837
Pfizer
Completed
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

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