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Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.


Phase 1
18 Years
50 Years
Not Enrolling
Both
Breast Cancer, Tumors, Leukemia

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Trial Information

Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.

Outcome Time Frame:

5 weeks

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

Netherlands: Independent Ethics Committee

Study ID:

3160A4-1114

NCT ID:

NCT00777530

Start Date:

April 2008

Completion Date:

August 2008

Related Keywords:

  • Breast Cancer
  • Tumors
  • Leukemia
  • Breast Neoplasms
  • Leukemia

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