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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032690
• Other study ID #: B1871062
• Secondary ID: 2021-004911-24
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2022
• Est. completion date: June 25, 2022

Study information

• Verified date: July 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 25, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
Belgium	Brussels Clinical Research Unit	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]		6 days
Primary	Cmax		6 days
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		6 days
Secondary	Time to Cmax (Tmax)		6 days
Secondary	Apparent Oral Clearance (CL/F)		6 days
Secondary	Apparent Volume of Distribution (Vz/F)		6 days
Secondary	Plasma elimination half-life (t1/2)		6 days

External Links

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