Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects

This study has been completed.

First Received: July 22, 2008 Last Updated: February 5, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00721474

Purpose

A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.

Condition	Intervention	Phase
Healthy Subjects	Drug: Bosutinib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Bosutinib

Further study details as provided by Wyeth:

Primary Outcome Measures:

Pharmacokinetics (plasma concentrations) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bosutinib fasting	Drug: Bosutinib Bosutinib fasting
2: Experimental Bosutinib fed	Drug: Bosutinib Bosutinib fed

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721474

Locations

United States, Washington

Tacoma, Washington, United States, 98418

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:	3160A4-1110
Study First Received:	July 22, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00721474 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 09, 2009