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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00757341
First received: September 19, 2008
Last updated: April 24, 2009
Last verified: April 2009
History of Changes
  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 1

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: An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled Bosutinib in Healthy Male Subjects

Resource links provided by NLM:

Drug Information available for: Bosutinib
U.S. FDA Resources

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

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
Experimental: SKI-606 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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00757341     History of Changes
Other Study ID Numbers: 3160A4-1112-US
Study First Received: September 19, 2008
Last Updated: April 24, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013