Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2022-01-27

Brief Summary

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This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. Statistical analyses will be performed comparing these parameters calculated after administration of a single 500 mg dose with the intact capsule formulation (100 mg x 5) as the Reference treatment and the capsule contents mixed with applesauce or yogurt (100 mg x 5) as the Test treatments.

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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, 6-sequence, crossover study in healthy participants

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bosutinib capsule contents mixed with applesauce

Bosutinib capsule contents mixed with applesauce to healthy participants

Group Type EXPERIMENTAL

Bosutinib capsule

Intervention Type DRUG

500 mg dose of bosutinib capsule contents mixed with applesauce

Bosutinib capsule contents mixed with yogurt

Bosutinib capsule contents mixed with yogurt to healthy participants

Group Type EXPERIMENTAL

Bosutinib capsule

Intervention Type DRUG

500 mg dose of bosutinib capsule contents mixed with yogurt

Bosutinib intact capsules

Bosutinib intact capsules to healthy participants

Group Type ACTIVE_COMPARATOR

Bosutinib capsule

Intervention Type DRUG

500 mg dose of intact bosutinib capsules

Interventions

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Bosutinib capsule

500 mg dose of bosutinib capsule contents mixed with applesauce

Intervention Type DRUG

Bosutinib capsule

500 mg dose of bosutinib capsule contents mixed with yogurt

Intervention Type DRUG

Bosutinib capsule

500 mg dose of intact bosutinib capsules

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 54 years of age, inclusive, at the time of signing the informed consent document (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.
* 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:

1. estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) \< 90 mL/min/1.73 m2;
2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \> upper limit of normal (ULN);
3. 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;
4. Amylase and lipase levels \> ULN.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes