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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04549480
• Collaborator: (none)
• Enrollment: 66
• Locations: 2
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site: 33
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Bosutinib capsule; Drug: Bosutinib tablet	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Sep 16, 2020
• Actual Primary Completion Date: Jan 15, 2021
• Actual Study Completion Date: Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bosutinib capsule Bosutinib pediatric capsule to healthy participants	Drug: Bosutinib capsule; 100 mg dose of bosutinib pediatric capsule
Active Comparator: Bosutinib tablet Bosutinib tablet to healthy participants	Drug: Bosutinib tablet; 100 mg dose of bosutinib tablet

Outcome Measures

Primary Outcome Measures

1. 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)]

2. Maximum Observed Plasma Concentration (Cmax) [6 days]

   Maximum Observed Plasma Concentration (Cmax)

Secondary Outcome Measures

1. 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)

2. Time to Cmax (Tmax) [6 days]

   Time to Cmax (Tmax)

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 54 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Groningen		Netherlands	9728 NZ
2	PRA Health Sciences Utrecht	Utrecht		Netherlands	3584 BL

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04549480
• Other Study ID Numbers: B1871061; 2020-002782-34
• First Posted: Sep 16, 2020
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: bosutinib,; bioequivalence,; Cmax,; AUC
• Additional relevant MeSH terms: Malnutrition

Study Results

No Results Posted as of Feb 16, 2022