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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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Breast Cancer, Leukemia, Myeloid, Chronic

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Blood samples

Outcome Time Frame:

5 weeks

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

Poland: Ministry of Health

Study ID:

3160A4-1111

NCT ID:

NCT00759837

Start Date:

October 2008

Completion Date:

May 2009

Related Keywords:

  • Breast Cancer
  • Leukemia, Myeloid, Chronic
  • Breast Neoplasms
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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