Study Evaluating The Mass Balance And Metabolic Disposition Of SKI-606

This study has been completed.

First Received: September 19, 2008 Last Updated: April 24, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00757341

Purpose

This study will assess the mass balance, metabolic disposition, and identification of metabolites following single oral administration of [14C]-SKI-606 in healthy male subjects.

Condition	Intervention	Phase
Healthy Subjects	Drug: SKI-606	Phase I

Drug Information available for: Bosutinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled Bosutinib in Healthy Male Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

Mass Balance and Metabolic Disposition [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	December 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SKI-606: Experimental	Drug: SKI-606

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Healthy men, aged 18 to 50 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757341

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:	3160A4-1112-US
Study First Received:	September 19, 2008
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00757341 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 May 07, 2009