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PN400

Phase 1

Platelet Inhibition | Small molecule | Hematology |AstraZeneca PLC|Trials Updated: Dec 7, 2010

PN400 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

PN400 clinical trials

PN400 · 1 trial · 1 indication

Phase 1 1
NCT01094483A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose AspirinPlatelet Inhibition
COMPLETED40 Analytics
PHASE1COMPLETED
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin
Platelet InhibitionUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacodynamic: Mean percent inhibition of serum thromboxane B2
measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2
Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events
during approx 6 week study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPN400 + ASA
2PLACEBO_COMPARATORPlacebo + ASA

Interventions

NameTypeDescription
PN400DRUGnaproxen 500 mg/esomeprazole 20 mg oral tablet
ASADRUGAsprin 81 mg enteric coated tablet
PlaceboDRUG -
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Eligibility Criteria

Age Range50 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Stable without clinically significant disease Exclusion Criteria: * Use of NSAID within 2 weeks * Type 1 or 2 DM * GI disorder

Countries:United States
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Frequently asked questions about PN400

What is PN400?

PN400 is an investigational small molecule developed by AstraZeneca PLC for platelet inhibition in hematology. It is a Phase 1 clinical candidate, meaning it has not been approved by the FDA and remains in early-stage development. The program has completed one Phase 1 trial with 40 participants.

What is PN400 used for?

PN400 is being developed for platelet inhibition. Its only completed clinical trial enrolled healthy volunteers aged 50 years and older to assess inhibition of serum thromboxane B2 levels. The drug is investigational and has not been approved for any indication.

Who makes PN400?

PN400 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the single completed Phase 1 trial of PN400 conducted in the United States.

What phase is PN400 in?

PN400 is in Phase 1 development. One Phase 1 trial has been completed, and there are no active trials. The drug is investigational and has not received FDA approval. The completed study was randomized, double-blind, and placebo-controlled, enrolling 40 healthy volunteers.

What clinical trials is PN400 in?

PN400 has been studied in one completed Phase 1 trial, NCT01094483, titled "A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin." It enrolled 40 healthy volunteers in the United States and was randomized, double-blind, and placebo-controlled.