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Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition

Primary Purpose

Healthy Participants

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Bosutinib capsule

About this trial

This is an interventional basic science trial for Healthy Participants focused on measuring Bioavailability, bosutinib, Maximum Observed Plasma Concentration (Cmax), Area Under the Curve (AUC)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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 informed consent document (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.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
1. estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) < 90 mL/min/1.73 m2;
2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > upper limit of normal (ULN);
3. Serum (total and direct) bilirubin level > ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN;
4. Amylase and lipase levels > ULN.

Sites / Locations

Brussels Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Bosutinib capsule contents mixed with applesauce

Bosutinib capsule contents mixed with yogurt

Bosutinib intact capsules

Arm Description

Bosutinib capsule contents mixed with applesauce to healthy participants

Bosutinib capsule contents mixed with yogurt to healthy participants

Bosutinib intact capsules to healthy participants

Outcomes

Primary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]

Cmax

Secondary Outcome Measures

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Time to Cmax (Tmax)

Apparent Oral Clearance (CL/F)

Apparent Volume of Distribution (Vz/F)

Plasma elimination half-life (t1/2)

Full Information

NCT ID

NCT04916769

First Posted

June 1, 2021

Last Updated

February 9, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04916769

Brief Title

Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition

Official Title

A PHASE 1, OPEN-LABEL, RANDOMIZED, 3-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOAVAILABILITY OF BOSUTINIB ADMINISTERED AS CAPSULE CONTENTS MIXED WITH APPLESAUCE OR YOGURT RELATIVE TO INTACT CAPSULES IN HEALTHY PARTICIPANTS UNDER FED CONDITION

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

August 13, 2021 (Actual)

Primary Completion Date

January 27, 2022 (Actual)

Study Completion Date

January 27, 2022 (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

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. Statistical analyses will be performed comparing these parameters calculated after administration of a single 500 mg dose with the intact capsule formulation (100 mg x 5) as the Reference treatment and the capsule contents mixed with applesauce or yogurt (100 mg x 5) as the Test treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Participants

Keywords

Bioavailability, bosutinib, Maximum Observed Plasma Concentration (Cmax), Area Under the Curve (AUC)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

A Phase 1, open-label, randomized, single dose, 3-period, 6-sequence, crossover study in healthy participants

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bosutinib capsule contents mixed with applesauce

Arm Type

Experimental

Arm Description

Bosutinib capsule contents mixed with applesauce to healthy participants

Arm Title

Bosutinib capsule contents mixed with yogurt

Arm Type

Experimental

Arm Description

Bosutinib capsule contents mixed with yogurt to healthy participants

Arm Title

Bosutinib intact capsules

Arm Type

Active Comparator

Arm Description

Bosutinib intact capsules to healthy participants

Intervention Type

Drug

Intervention Name(s)

Bosutinib capsule

Intervention Description

500 mg dose of bosutinib capsule contents mixed with applesauce

Intervention Type

Drug

Intervention Name(s)

Bosutinib capsule

Intervention Description

500 mg dose of bosutinib capsule contents mixed with yogurt

Intervention Type

Drug

Intervention Name(s)

Bosutinib capsule

Intervention Description

500 mg dose of intact bosutinib capsules

Primary Outcome Measure Information:

Title

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]

Time Frame

6 days

Title

Cmax

Time Frame

6 days

Secondary Outcome Measure Information:

Title

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Time Frame

6 days

Title

Time to Cmax (Tmax)

Time Frame

6 days

Title

Apparent Oral Clearance (CL/F)

Time Frame

6 days

Title

Apparent Volume of Distribution (Vz/F)

Time Frame

6 days

Title

Plasma elimination half-life (t1/2)

Time Frame

6 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

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 informed consent document (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. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) < 90 mL/min/1.73 m2; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > upper limit of normal (ULN); Serum (total and direct) bilirubin level > ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN; Amylase and lipase levels > ULN.

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

Brussels Clinical Research Unit

City

Brussels

State/Province

Bruxelles-capitale, Région DE

ZIP/Postal Code

B-1070

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

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=B1871063

Description

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Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition

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