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.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00721474
First received: July 22, 2008
Last updated: February 5, 2009
Last verified: February 2009

July 22, 2008
February 5, 2009
September 2008
September 2008   (final data collection date for primary outcome measure)
Pharmacokinetics (plasma concentrations) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721474 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
  • Drug: Bosutinib
    Bosutinib fasting
  • Drug: Bosutinib
    Bosutinib fed
  • Experimental: 1
    Bosutinib fasting
    Intervention: Drug: Bosutinib
  • Experimental: 2
    Bosutinib fed
    Intervention: Drug: Bosutinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721474
3160A4-1110
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP