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
  Purpose

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 Intervention Phase
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Drug: Bosutinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 88
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 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
Experimental: Cohort 2 Drug: Bosutinib
4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition
Other Name: SKI-606, PF-05208763

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374139

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01374139     History of Changes
Other Study ID Numbers: B1871035
Study First Received: June 7, 2011
Last Updated: November 28, 2011
Health Authority: Singapore: Health Sciences Authority (HSA)

Keywords provided by Pfizer:
Bosutinib
Bioequivalence and Food Effect Studies

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014