Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Bosutinib; Drug: Lansoprazole

• Registration Number: NCT00952913
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-18
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old.

Exclusion Criteria

• Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bosutinib	Bosutinib
2	Bosutinib	bosutinib + lansoprazole
2	Lansoprazole	bosutinib + lansoprazole

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2	1 month

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Miami, Florida, United States