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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

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ClinicalTrials.gov Identifier: NCT00721474
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Bosutinib Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
Bosutinib fasting
Drug: Bosutinib
Bosutinib fasting
Experimental: 2
Bosutinib fed
Drug: Bosutinib
Bosutinib fed



Primary Outcome Measures :
  1. Pharmacokinetics (plasma concentrations) [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men, age 18-50;
  • Healthy women of nonchildbearing potential, age 18-50.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721474


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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00721474     History of Changes
Other Study ID Numbers: 3160A4-1110
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009