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

This study has been completed.

First Received on August 3, 2009. Last Updated on April 18, 2011 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00952913

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Bosutinib Drug: Lansoprazole	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Lansoprazole Bosutinib

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2 [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	August 2009
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Bosutinib	Drug: Bosutinib 4 x 100-mg oral tablets, single dose Other Name: SKI-606
Experimental: 2 bosutinib + lansoprazole	Drug: Bosutinib 4 x 100-mg oral tablets, single dose Other Name: SKI-606 Drug: Lansoprazole 2 x 30-mg oral tablets, single daily doses for 2 days Other Name: Prevacid

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952913

Locations

United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33126

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00952913 History of Changes
Other Study ID Numbers:	3160A4-1108, B1871002
Study First Received:	August 3, 2009
Last Updated:	April 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012