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ARRY-300, MEK inhibitor;

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 6, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00828165A Safety Study of ARRY-300 in Healthy SubjectsPHASE1 COMPLETED 12 — — Jan 1, 2009Apr 1, 2009Oct 6, 20201 United States
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Study Endpoints
Primary Endpoints
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Duration of study
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
Following a single dose
Secondary Endpoints
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Duration of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
ARRY-300EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
ARRY-300, MEK inhibitor; oralDRUGsingle dose, escalating
PlaceboDRUGmatching placebo
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Healthy male or female (females must be of non-childbearing potential) between the ages of 18 and 50 years, inclusive. * Body mass index (BMI) of 18 kg/m2 to 35 kg/m2; and a total body weight \> 50 kg (110 lbs) and \< 113 kg (280 lbs). * Additional criteria exist. Key Exc...

Countries:United States
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