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Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule

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ClinicalTrials.gov Identifier: NCT05032690
Recruitment Status : Completed
First Posted : September 2, 2021
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a single 100 mg capsule of bosutinib relative to fasted condition in adults healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extend of absorption (Cmax, AUC). Statistical analyses will be performed after the administration of a single 100 mg dose under fed condition as the Reference treatment and the four 25 mg capsules as the Test treatment for the first comparison, and after administration of a single 100 mg dose under fasted condition as the Reference treatment and the 100 mg capsule under fed condition as the Test treatment for the second comparison.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Bosutinib capsule Drug: Bosutinib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A Phase 1, open-label, randomized, single dose, 3-period, 4 sequence, crossover study in healthy participants
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, 4-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY TO COMPARE THE BIOAVAILABILITY OF ORALLY ADMINISTERED BOSUTINIB CAPSULES AND TO ESTIMATE THE EFFECT OF FOOD ON BOSUTINIB CAPSULE
Actual Study Start Date : January 19, 2022
Actual Primary Completion Date : June 25, 2022
Actual Study Completion Date : June 25, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bosutinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment B: Bosutinib four 25 mg capsule after meal
Bosutinib four 25 mg capsule taken after a high-fat and high-calorie breakfast for comparison 1
 Drug: Bosutinib capsule
Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast
Active Comparator: Treatment A: Bosutinib 100 mg capsule after meal (active comparator)
Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast for comparison 1
 Drug: Bosutinib capsule
Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast
Experimental: Treatment A: Bosutinib 100 mg capsule after meal (experimental)
Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast for comparison 2
 Drug: Bosutinib capsule
Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast
Active Comparator: Treatment C: Bosutinib 100 mg capsule after fasting
Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours for comparison 2
 Drug: Bosutinib
Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] [ Time Frame: 6 days ]
  2. Cmax [ Time Frame: 6 days ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 6 days ]
  2. Time to Cmax (Tmax) [ Time Frame: 6 days ]
  3. Apparent Oral Clearance (CL/F) [ Time Frame: 6 days ]
  4. Apparent Volume of Distribution (Vz/F) [ Time Frame: 6 days ]
  5. Plasma elimination half-life (t1/2) [ Time Frame: 6 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female participants of non-childbearing potential and/or male participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD)
  • participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination, vital signs which include BP and pulse rate measurement, clinical laboratory tests, and electrocardiogram (ECG).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

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 (eg, gastrectomy, cholecystectomy).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg,hepatitis B surface antigen (HBcAb) or hepatitis C antibody (HCVAb).

  • 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 level > ULN.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032690


Locations
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Belgium
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05032690    
Other Study ID Numbers: B1871062
2021-004911-24 ( EudraCT Number )
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Bioavailability
Food Effect
Bosutinib
Maximum Observed Plasma Concentration (Cmax)
Area Under the Curve (AUC)
Additional relevant MeSH terms:
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Bosutinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action