Back to resultsBioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
Primary Purpose
Healthy Participants
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Bosutinib capsule
Bosutinib tablet
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Participants focused on measuring bosutinib,, bioequivalence,, Cmax,, AUC
Eligibility Criteria
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.
Sites / Locations
- PRA Health Sciences
- PRA Health Sciences Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bosutinib capsule
Bosutinib tablet
Arm Description
Bosutinib pediatric capsule to healthy participants
Bosutinib tablet to healthy participants
Outcomes
Primary Outcome Measures
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)]
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Secondary Outcome Measures
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time to Cmax (Tmax)
Time to Cmax (Tmax)
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.
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.
Plasma elimination half-life (t1/2)
Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04549480
Brief Title
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
bosutinib,, bioequivalence,, Cmax,, AUC
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bosutinib capsule
Arm Type
Experimental
Arm Description
Bosutinib pediatric capsule to healthy participants
Arm Title
Bosutinib tablet
Arm Type
Active Comparator
Arm Description
Bosutinib tablet to healthy participants
Intervention Type
Drug
Intervention Name(s)
Bosutinib capsule
Intervention Description
100 mg dose of bosutinib pediatric capsule
Intervention Type
Drug
Intervention Name(s)
Bosutinib tablet
Intervention Description
100 mg dose of bosutinib tablet
Primary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]
Description
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]
Time Frame
6 days
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Maximum Observed Plasma Concentration (Cmax)
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame
6 days
Title
Time to Cmax (Tmax)
Description
Time to Cmax (Tmax)
Time Frame
6 days
Title
Apparent Oral Clearance (CL/F)
Description
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame
6 days
Title
Apparent Volume of Distribution (Vz/F)
Description
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.
Time Frame
6 days
Title
Plasma elimination half-life (t1/2)
Description
Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
Facility Name
PRA Health Sciences Utrecht
City
Utrecht
ZIP/Postal Code
3584 BL
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B1871061
Description
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Learn more about this trial
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
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