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ARRY-300, MEK inhibitor

Phase 1

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

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 used for?

ARRY-300 is an investigational small molecule MEK inhibitor being studied in healthy volunteers. It is not approved for any indication and is in early clinical development. A Phase 1 trial evaluated its safety in healthy subjects, but it is not being developed for a specific disease at this time.

What does ARRY-300 target?

ARRY-300 targets MEK, a kinase enzyme involved in cell signaling pathways. By inhibiting MEK, it may interfere with cellular proliferation and survival. This mechanism is being explored in early clinical research, though the drug is currently studied only in healthy subjects.

Who makes ARRY-300?

Pfizer, Inc. (NYSE: PFE) is developing ARRY-300. The company is conducting clinical research on this investigational MEK inhibitor, which is currently in Phase 1 development.

What phase is ARRY-300 in?

ARRY-300 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage research.

What clinical trials is ARRY-300 in?

ARRY-300 has one completed Phase 1 trial, NCT00828165, titled 'A Safety Study of ARRY-300 in Healthy Subjects.' This randomized, double-blind, placebo-controlled study enrolled 12 participants in the United States and evaluated the drug's safety in healthy adults aged 18 and older.