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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2022-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A Phase 1, open-label, randomized, single dose, 3-period, 4 sequence, crossover study in healthy participants

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Bosutinib capsule

Intervention Type DRUG

Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast

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

Group Type ACTIVE_COMPARATOR

Bosutinib capsule

Intervention Type DRUG

Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast

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

Group Type EXPERIMENTAL

Bosutinib capsule

Intervention Type DRUG

Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast

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

Group Type ACTIVE_COMPARATOR

Bosutinib

Intervention Type DRUG

Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours

Interventions

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Bosutinib capsule

Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast

Intervention Type DRUG

Bosutinib capsule

Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast

Intervention Type DRUG

Bosutinib

Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours

Intervention Type DRUG

Bosutinib capsule

Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes