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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549480
• Other study ID #: B1871061
• Secondary ID: 2020-002782-34
• Status: Completed
• Phase: Phase 1
• Start date: September 16, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Healthy Participants
• Malnutrition

Intervention

Drug:
• Bosutinib capsule
100 mg dose of bosutinib pediatric capsule
• Bosutinib tablet
100 mg dose of bosutinib tablet

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen
Netherlands	PRA Health Sciences Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	6 days
Secondary	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
Secondary	Time to Cmax (Tmax)	Time to Cmax (Tmax)	6 days
Secondary	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
Secondary	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
Secondary	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

External Links

•   To obtain contact information for a study center near you, click here.