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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Warsaw, , 02-507 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00759837
Pfizer
Completed
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

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Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
  • Breast Cancer
  • Leukemia, Myeloid, Chronic
Drug: Bosutinib
Experimental: 1
Intervention: Drug: Bosutinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
May 2009
May 2009   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
Russian Federation
 
NCT00759837
3160A4-1111
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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