Breast Cancer, Leukemia, Tumors
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.
Interventions
DRUGBosutinib (SKI-606)
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive on study day 1. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone \[FSH\] ≥ 38 mIU/mL) and must have a negative serum pregnancy test result before administration of test article. 2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg. 3. Healthy as determined by the investigator on the basis of screening evaluations.
Exclusion criteria
1. Family history QT prolongation, syncope, seizure, or unexplained cardiac related death. 2. Presence or history of any disorder that may prevent the successful completion of the study. 3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Blood samples | 5 weeks |
Countries
Netherlands
Outcome results
None listed