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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Abnormal Karyotype
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014