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Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Primary Purpose

Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Bosutinib

About this trial

This is an interventional treatment trial for Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML) focused on measuring Bosutinib, Bioequivalence and Food Effect Studies

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Outcomes

Primary Outcome Measures

Plasma Cmax for bosutinib.

AUCt for bosutinib.

Plasma AUCinf for bosutinib.

AUClast for bosutinib.

Tmax for bosutinib.

t½ for bosutinib.

Secondary Outcome Measures

Full Information

NCT ID

NCT01374139

First Posted

June 7, 2011

Last Updated

November 28, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01374139

Brief Title

Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

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 Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Keywords

Bosutinib, Bioequivalence and Food Effect Studies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Title

Cohort 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bosutinib

Other Intervention Name(s)

SKI-606, PF-05208763

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bosutinib

Other Intervention Name(s)

SKI-606, PF-05208763

Intervention Description

4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition

Primary Outcome Measure Information:

Title

Plasma Cmax for bosutinib.

Time Frame