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

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

Tracking Information

• First Submitted Date: August 27, 2021
• First Posted Date: September 2, 2021
• Last Update Posted Date: July 8, 2022
• Actual Study Start Date: January 19, 2022
• Actual Primary Completion Date: June 25, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 27, 2021)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] [ Time Frame: 6 days ]
• Cmax [ Time Frame: 6 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 27, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

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

• Condition: Healthy Participants

Intervention

• Drug: Bosutinib capsule
  Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast
• Drug: Bosutinib capsule
  Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast
• Drug: Bosutinib
  Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours
• Drug: Bosutinib capsule
  Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast

Study Arms

• 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
  Intervention: Drug: Bosutinib capsule
• 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
  Intervention: Drug: Bosutinib capsule
• 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
  Intervention: Drug: Bosutinib capsule
• 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
  Intervention: Drug: Bosutinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 24, 2022): 32
• Original Estimated Enrollment (submitted: August 27, 2021): 28
• Actual Study Completion Date: June 25, 2022
• Actual Primary Completion Date: June 25, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT05032690
• Other Study ID Numbers: B1871062; 2021-004911-24 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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.

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: July 2022