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Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Utrecht, , 3584 Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Tumors, Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00777530
Pfizer
Completed
Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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