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

Pfizer1 site in 1 country20 target enrollmentMay 2014

ConditionsHealthy

Interventionsbosutinib or bosutinib + aprepitant

Drugsbosutinib or bosutinib + aprepitant

Overview

Phase: Phase 1
Intervention: bosutinib or bosutinib + aprepitant
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 20
Locations: 1
Primary Endpoint: Area under the Concentration-Time Curve (AUC)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

June 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Healthy volunteers

Healthy volunteers taking a single dose of bosutinib and a single dose of bosutinib plus aprepitant in random order

Intervention: bosutinib or bosutinib + aprepitant

Outcomes

Primary Outcomes

Area under the Concentration-Time Curve (AUC)

Time Frame: 96 hours

AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.

Maximum Observed Plasma Concentration (Cmax)

Time Frame: 96 hours

Cmax is the peak concentration.

Secondary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(96 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax)(96 hours)
Plasma Decay Half-Life (t1/2)(96 hours)
Apparent Oral Clearance (CL/F)(96 hours)
Apparent Volume of Distribution (Vz/F)(96 hours)