Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

Phase 1

Completed

• Conditions: Breast Cancer; Tumors; Leukemia
• Interventions: Drug: Bosutinib (SKI-606)

• Registration Number: NCT00777530
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2008-10
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Last Update Submitted: 2008-10-22
• Last Update Posted: 2008-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bosutinib (SKI-606)	-

Primary 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

Secondary Outcome Measures

Name	Time	Method
Blood samples	5 weeks