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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759837
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : July 16, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Leukemia, Myeloid, Chronic Drug: Bosutinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Bosutinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Study Start Date : October 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
Drug Information available for: Bosutinib

Arm Intervention/treatment
Experimental: 1 Drug: Bosutinib

Primary Outcome Measures :
  1. Blood samples [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00759837

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Warsaw, Poland, 02-507
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00759837     History of Changes
Other Study ID Numbers: 3160A4-1111
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: July 16, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases