A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

Study Overview
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Brief Summary
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This is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. The primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single oral dose of bosutinib in healthy subjects.

Official Title
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An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Dose Of Aprepitant, A Moderate CYP3A Inhibitor On Bosutinib Administered Orally To Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: bosutinib or bosutinib + aprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects with an informed consent document signed and dated by the subject. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol . Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers<br>Healthy volunteers taking a single dose of bosutinib and a single dose of bosutinib plus aprepitant in random order | Drug: bosutinib or bosutinib + aprepitant<br>* Single dose of bosutinib (500 mg) or single dose of bosutinib (500 mg) and aprepitant (125 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. | 96 hours | 
| Maximum Observed Plasma Concentration (Cmax) | Cmax is the peak concentration. | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 96 hours | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax is measure how fast a drug is absorbed | 96 hours | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 96 hours | 
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 96 hours | 
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bosutinib, aprepitant, drug interaction, healthy volunteers, pharmacokinetics, chronic myelogenous leukemia