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infusion of bosutinib

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 31, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02192294Absolute Bioavailability Of BosutinibPHASE1 COMPLETED 14Aug 1, 2014Oct 1, 2014Oct 31, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
Area under the Concentration-Time Curve (AUC)
96 hours

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

Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax)
96 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
96 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
96 hours
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Study Design & Arms
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
BosutinibEXPERIMENTAL -
Interventions
NameTypeDescription
Oral BosutinibDRUGa single dose of 500 mg oral bosutinib
Intravenous infusion of bosutinibDRUGa single dose of 120 mg of bosutinib intravenous infusion (1 hour)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects (of non-childbearing potential). * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * Subjects who are willing and able to comply with al...

Countries:United Kingdom
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