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ARRY-300, MEK inhibitor

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 6, 2020

Target and mechanism

Molecular targetMET
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

ARRY-300, MEK inhibitor · 1 trial · 1 indication

Phase 1 1
NCT00828165A Safety Study of ARRY-300 in Healthy SubjectsHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
A Safety Study of ARRY-300 in Healthy Subjects
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about ARRY-300, MEK inhibitor

What is ARRY-300?

ARRY-300 is an oral small molecule drug candidate developed by Pfizer, Inc. (ticker PFE). It is an inhibitor that targets MET. It has been studied in a Phase 1 clinical trial in healthy adult subjects, and it is investigational rather than an approved medicine.

What does ARRY-300 target?

ARRY-300 targets MET. It is an inhibitor of that molecular target, and it is described as a small molecule drug candidate. The MET target is the basis for how ARRY-300 is designed to act, and the compound has been tested in a Phase 1 study in healthy subjects.

Who makes ARRY-300?

Pfizer, Inc. is the developer of ARRY-300. The company trades under the ticker PFE. Pfizer has advanced ARRY-300 into Phase 1 clinical development, where it has been evaluated in a single completed study of healthy adult subjects.

What phase is ARRY-300 in?

ARRY-300 is in Phase 1 development. It is an investigational drug candidate and is not approved. One Phase 1 trial of ARRY-300 has been completed, and no active trials are ongoing. The completed study enrolled 12 healthy adult subjects.

What clinical trials is ARRY-300 in?

ARRY-300 has been studied in one completed Phase 1 trial, NCT00828165, titled A Safety Study of ARRY-300 in Healthy Subjects. That trial enrolled 12 healthy adult participants in the United States. It was randomized, double blind, and placebo controlled.

Is ARRY-300 the same as ARRY-300, MEK inhibitor?

ARRY-300 is also referred to as ARRY-300, MEK inhibitor, and it is described as an oral drug candidate. These names refer to the same compound developed by Pfizer, Inc. (ticker PFE). It targets MET and has been evaluated in a completed Phase 1 study in healthy subjects.