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bosutinib or bosutinib+ aprepitant

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 24, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

bosutinib or bosutinib+ aprepitant · 1 trial · 1 indication

Phase 1 1
NCT02058277A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy VolunteersHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers
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Study Endpoints

Primary Endpoints

Area under the Concentration-Time Curve (AUC)
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)
96 hours

Cmax is the peak concentration.

Secondary Endpoints

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
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Study Design & Arms

MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

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

Interventions

NameTypeDescription
bosutinib or bosutinib + aprepitantDRUGSingle dose of bosutinib (500 mg) or single dose of bosutinib (500 mg) and aprepitant (125 mg)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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, neur...

Countries:United States
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