Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374139
• Other study ID #: B1871035
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2011
• Last updated: November 28, 2011
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority (HSA)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Karyotype
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Philadelphia Chromosome
• Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Intervention

Drug:
• Bosutinib
5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition
• Bosutinib
4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Cmax for bosutinib.		96 hr post dose in each period	No
Primary	AUCt for bosutinib.		96 hr post dose in each period	No
Primary	Plasma AUCinf for bosutinib.		96 hr post dose in each period	No
Primary	AUClast for bosutinib.		96 hr post dose in each period	No
Primary	Tmax for bosutinib.		96 hr post dose in each period	No
Primary	t½ for bosutinib.		96 hr post dose in each period	No

External Links

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