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OpenTrials
Completed

NCT Number: NCT01374139

Bioequivalence And Food Effect Study Of Bosutinib 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).

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Key information

Conditions

Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML) Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosutinib

Drug

5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition

Other names: SKI-606, PF-05208763

Primary outcomes

  1. Plasma Cmax for bosutinib.

    Time frame: 96 hr post dose in each period

  2. AUCt for bosutinib.

    Time frame: 96 hr post dose in each period

  3. Plasma AUCinf for bosutinib.

    Time frame: 96 hr post dose in each period

  4. AUClast for bosutinib.

    Time frame: 96 hr post dose in each period

  5. Tmax for bosutinib.

    Time frame: 96 hr post dose in each period

  6. t½ for bosutinib.

    Time frame: 96 hr post dose in each period

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2011
Registry last updated
Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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