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

This study is not yet open for participant recruitment.

Verified by Wyeth, August 2009

First Received: August 3, 2009 Last Updated: August 4, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
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:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

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

Arms	Assigned Interventions
1: Experimental bosutinib	Drug: Bosutinib
2: Experimental bosutinib + lansoprazole	Drug: Bosutinib Drug: Lansoprazole

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

Contacts

Contact: Trial Manager

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3160A4-1108
Study First Received:	August 3, 2009
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00952913 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

healthy subjects

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Lansoprazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010