Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

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

Treatments: Drug: Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01374139

B1871035

Details and patient eligibility

About

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).

Enrollment: 88 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Cohort 1

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Cohort 2

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib