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ARRY-502

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 5, 2020

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01349725A Safety Study of ARRY-502 in Healthy SubjectsPHASE1 COMPLETED 32 — — May 1, 2011Sep 1, 2011Oct 5, 20201 United States
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Study Endpoints
Primary Endpoints
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.
3 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
2 weeks
Secondary Endpoints
Characterize the pharmacodynamics of the study drug as determined by laboratory assays.
2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
ARRY-502EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ARRY-502DRUGOral; multiple dose, escalating
PlaceboDRUGOral; matching placebo
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Healthy male or female between the ages of 18 and 50 years. * Females must be of nonchildbearing potential. * Body mass index (BMI) of 18 to 32 and a total body weight \> 50 kg (110 lbs) and \< 114 kg (250 lbs). * Additional criteria exist. Key Exclusion Criteria: * Evid...

Countries:United States
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