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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00759837
First received: September 23, 2008
Last updated: July 15, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Breast Cancer
Leukemia, Myeloid, Chronic
Drug: Bosutinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Blood samples [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 27
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Bosutinib

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759837

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

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00759837     History of Changes
Other Study ID Numbers: 3160A4-1111
Study First Received: September 23, 2008
Last Updated: July 15, 2009
Health Authority: Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014