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Completed

NCT Number: NCT04549480

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosutinib capsule

Drug

100 mg dose of bosutinib pediatric capsule

Bosutinib tablet

Drug

100 mg dose of bosutinib tablet

Primary outcomes

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

    Time frame: 6 days

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

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 6 days

    Maximum Observed Plasma Concentration (Cmax)

Secondary outcomes

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

    Time frame: 6 days

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

  2. Time to Cmax (Tmax)

    Time frame: 6 days

    Time to Cmax (Tmax)

  3. Apparent Oral Clearance (CL/F)

    Time frame: 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)

    Time frame: 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)

    Time frame: 6 days

    Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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