Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
- Registration Number
- NCT00759837
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Bosutinib -
- Primary Outcome Measures
Name Time Method Blood samples 5 weeks
- Secondary Outcome Measures
Name Time Method Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. 5 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of bosutinib's BCR-ABL tyrosine kinase inhibition are affected by hepatic impairment in NCT00759837?
How does bosutinib's pharmacokinetic profile in chronic hepatic impairment compare to standard-of-care tyrosine kinase inhibitors like imatinib?
Which biomarkers correlate with bosutinib efficacy or toxicity in patients with chronic myeloid leukemia and liver dysfunction?
What adverse events were observed in NCT00759837 for bosutinib-treated subjects with Child-Pugh liver disease classifications?
How do bosutinib's safety outcomes in hepatically impaired patients inform its use in combination therapies for Ph+ ALL or CML?