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bosutinib or bosutinib+ aprepitant

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jun 24, 2014

bosutinib or bosutinib+ aprepitant target and mechanism

Molecular targetABL1, BCR, HCK, LYN, SRC
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

bosutinib or bosutinib+ aprepitant clinical trials

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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Frequently asked questions about bosutinib or bosutinib+ aprepitant

What is bosutinib?

Bosutinib is a small molecule kinase inhibitor developed by Pfizer, Inc. (ticker PFE). It is being studied in a Phase 1 drug interaction trial with aprepitant in healthy volunteers. The trial, NCT02058277, has been completed and enrolled 20 participants. Bosutinib is an investigational agent and has not been approved for the studied combination.

What does bosutinib target?

Bosutinib targets ABL1, BCR, HCK, LYN, and SRC kinases. It is classified as an inhibitor of these targets. This activity profile is relevant to its mechanism of action as a small molecule therapeutic.

Who makes bosutinib?

Bosutinib is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical trial evaluating bosutinib in combination with aprepitant.

What phase is bosutinib in?

Bosutinib is in Phase 1 clinical development. The only listed trial is a Phase 1 drug interaction study between bosutinib and aprepitant in healthy volunteers. This trial has been completed. Bosutinib is investigational and has not been approved for the studied combination.

What clinical trials is bosutinib in?

Bosutinib has been studied in one clinical trial: NCT02058277, titled "A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers." This Phase 1 trial was completed, enrolled 20 healthy volunteers, and was conducted in the United States. It was an uncontrolled, non-randomized study.