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
1 other identifier
interventional
24
1 country
1
Brief Summary
A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2008
CompletedFirst Posted
Study publicly available on registry
July 24, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFebruary 6, 2009
February 1, 2009
Same day
July 22, 2008
February 5, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics (plasma concentrations)
4 weeks
Study Arms (2)
1
EXPERIMENTALBosutinib fasting
2
EXPERIMENTALBosutinib fed
Interventions
Eligibility Criteria
You may qualify if:
- Healthy men, age 18-50;
- Healthy women of nonchildbearing potential, age 18-50.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tacoma, Washington, 98418, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 22, 2008
First Posted
July 24, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
February 6, 2009
Record last verified: 2009-02