Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01374139
First received: June 7, 2011
Last updated: November 28, 2011
Last verified: November 2011

June 7, 2011
November 28, 2011
August 2011
October 2011   (final data collection date for primary outcome measure)
  • Plasma Cmax for bosutinib. [ Time Frame: 96 hr post dose in each period ] [ Designated as safety issue: No ]
  • AUCt for bosutinib. [ Time Frame: 96 hr post dose in each period ] [ Designated as safety issue: No ]
  • Plasma AUCinf for bosutinib. [ Time Frame: 96 hr post dose in each period ] [ Designated as safety issue: No ]
  • AUClast for bosutinib. [ Time Frame: 96 hr post dose in each period ] [ Designated as safety issue: No ]
  • Tmax for bosutinib. [ Time Frame: 96 hr post dose in each period ] [ Designated as safety issue: No ]
  • t½ for bosutinib. [ Time Frame: 96 hr post dose in each period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01374139 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
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

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
  • Drug: Bosutinib
    5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition
    Other Name: SKI-606, PF-05208763
  • Drug: Bosutinib
    4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition
    Other Name: SKI-606, PF-05208763
  • Experimental: Cohort 1
    Intervention: Drug: Bosutinib
  • Experimental: Cohort 2
    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
88
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01374139
B1871035
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

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