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
NCT00721474
Last updated date
ABOUT THIS STUDY
A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.
FOR MORE INFORMATION
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Eligibility Criteria
condition
Healthy Subjects
Sex
Females and Males
Age
18-50 years
Inclusion Criteria
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- Healthy men, age 18-50;
- Healthy women of nonchildbearing potential, age 18-50.
Exclusion Criteria
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Advanced Information
Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief Summary | A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy Subjects | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 24 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2008 | |||
Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00721474 | |||
Other Study ID Numbers ICMJE | 3160A4-1110 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |