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Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01374139
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
2
Duration (Months)
43.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 2-Way Crossover Bioequivalence Study To Compare The Bosutinib Clinical Tablet And Clinical Capsule And To Investigate Food Effect On Bosutinib Commercial Formulation in Healthy Subjects
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Drug: Bosutinib
5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition
Other Names:
  • SKI-606, PF-05208763

    		•
    Experimental: Cohort 2

    Drug: Bosutinib
    4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition
    Other Names:
  • SKI-606, PF-05208763

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma Cmax for bosutinib. [96 hr post dose in each period]

    2. AUCt for bosutinib. [96 hr post dose in each period]

    3. Plasma AUCinf for bosutinib. [96 hr post dose in each period]

    4. AUClast for bosutinib. [96 hr post dose in each period]

    5. Tmax for bosutinib. [96 hr post dose in each period]

    6. t½ for bosutinib. [96 hr post dose in each period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive.

    • Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests.

    Exclusion Criteria:
    • Pregnant or nursing women or women of childbearing potential.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Singapore Singapore 188770

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01374139
    Other Study ID Numbers:
    • B1871035
    First Posted:
    Jun 15, 2011
    Last Update Posted:
    Nov 30, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by Pfizer
    Bosutinib
    Bioequivalence and Food Effect Studies
    Additional relevant MeSH terms:
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Philadelphia Chromosome

    Study Results

    No Results Posted as of Nov 30, 2011