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

Phase 1

Completed

• Conditions: Breast Cancer; Leukemia, Myeloid, Chronic
• Interventions: Drug: Bosutinib

• 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

Study Timeline

• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Study Start: 2008-10
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-15
• Last Update Posted: 2009-07-16

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