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CompletedNCT00759837Updated Jul 16, 2009

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

A Phase 1 interventional study of Bosutinib in Breast Cancer and Leukemia, Myeloid, Chronic, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-16.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Leukemia, Myeloid, Chronic
03

In context

Leukemia, Myeloid

2,443 studies on the registry are indexed under Leukemia, Myeloid; 210 are open to participants now.

This study's enrollment of 27 is below the median of 40 across 1,977 interventional studies indexed under Leukemia, Myeloid.

Browse Leukemia, Myeloid studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  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

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.

05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    1

    Drug: Bosutinib

Interventions

  • DrugBosutinib
06

What researchers measure

Primary outcomes

  1. Blood samples

    Time frame: 5 weeks

Secondary outcomes

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

    Time frame: 5 weeks

07

Study locations

1 site
  • Warsaw, 02-507, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00759837
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Sep 25, 2008
Start date
Oct 2008
Primary completion
May 2009
Completion
May 2009
Last update
Jul 16, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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