Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SKI-606 (Bosutinib)

• Registration Number: NCT01080365
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Study comparing 2 formulations of bosutinib in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-03
• Last Update Posted: 2010-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Men or women of nonchildbearing potential age 18 to 50 years

Exclusion Criteria

• Any clinically significant medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	SKI-606 (Bosutinib)	Commercial Tablet
2	SKI-606 (Bosutinib)	Clinical Tablet

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2	2 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Tacoma, Washington, United States