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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Bosutinib tablet; Drug: Bosutinib capsule

• Registration Number: NCT04549480
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study Start: 2020-09-16
• Study First Posted: 2020-09-16
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. 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.
2. 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.

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Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
2. Any condition possibly affecting drug absorption.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bosutinib tablet	Bosutinib tablet	Bosutinib tablet to healthy participants
Bosutinib capsule	Bosutinib capsule	Bosutinib pediatric capsule to healthy participants

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]	6 days	Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0-inf)\]
Maximum Observed Plasma Concentration (Cmax)	6 days	Maximum Observed Plasma Concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Apparent Oral Clearance (CL/F)	6 days	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Plasma elimination half-life (t1/2)	6 days	Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	6 days	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time to Cmax (Tmax)	6 days	Time to Cmax (Tmax)
Apparent Volume of Distribution (Vz/F)	6 days	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.

Trial Locations

Locations (2)

PRA Health Sciences Utrecht; 🇳🇱 Utrecht, Netherlands

PRA Health Sciences; 🇳🇱 Groningen, Netherlands