Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition

Study Overview
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Brief Summary
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This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. The comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100 mg x 1) as the Test treatment.

Official Title
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A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF BOSUTINIB PEDIATRIC CAPSULE AND THE COMMERCIAL TABLET FORMULATIONS IN HEALTHY PARTICIPANTS UNDER FED CONDITION

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Bosutinib capsule
* Drug: Bosutinib tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the ICD. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease. Any condition possibly affecting drug absorption.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bosutinib capsule<br>Bosutinib pediatric capsule to healthy participants | Drug: Bosutinib capsule<br>* 100 mg dose of bosutinib pediatric capsule<br>|
| Active Comparator: Bosutinib tablet<br>Bosutinib tablet to healthy participants | Drug: Bosutinib tablet<br>* 100 mg dose of bosutinib tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] | 6 days | 
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 6 days | 
| Time to Cmax (Tmax) | Time to Cmax (Tmax) | 6 days | 
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | 6 days | 
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | 6 days | 
| Plasma elimination half-life (t1/2) | Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half. | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bosutinib,, bioequivalence,, Cmax,, AUC