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AZD3161

Phase 1

Peripheral Neuropathic Pain | Small molecule | Pain |AstraZeneca PLC|Trials Updated: Apr 12, 2011

AZD3161 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2010

AZD3161 target and mechanism

Molecular targetSCN9A
Target classBlocker
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

AZD3161 clinical trials

AZD3161 · 1 trial · 2 indications

Phase 1 1
NCT01240148Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy VolunteersPeripheral Neuropathic Pain
COMPLETED26 Analytics
PHASE1COMPLETED
Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers
Peripheral Neuropathic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Results of mechanical pain testing using Quantitative Sensory Testing
Day 1

Secondary Endpoints

Number of participants with Adverse Events
Range of 14 days
Vital signs
Day 1
Clinical chemistry (urinalysis, hematology)
At follow up (a range of 8-15 days after Day 1)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL150 μL intradermal injection of 1 μmol/L AZD3161
2EXPERIMENTAL150 μL intradermal injection of 6 μmol/L AZD3161
3EXPERIMENTAL150 μL intradermal injection of 30 μmol/L AZD3161
4ACTIVE_COMPARATOR150 μL intradermal injection of 10 mg/mL Lidocaine
5PLACEBO_COMPARATOR150 μL intradermal injection of AZD3161 placebo

Interventions

NameTypeDescription
AZD3161DRUGSingle dose, intradermal injection
LidocaineDRUGSingle dose, intradermal injection
AZD3161 PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Caucasian male and female volunteers aged 18 to 55 years inclusive with suitable veins for venepuncture * The subject belongs to skin type II or III according to Fitzpatrick skin type scale * Females must have a negative pregnancy test at screening and at admission, mu...

Countries:United Kingdom
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Frequently asked questions about AZD3161

What is AZD3161?

AZD3161 is an investigational small molecule developed by AstraZeneca PLC for peripheral neuropathic pain. It has been studied in a Phase 1 clinical trial in healthy volunteers. AZD3161 is designed to block SCN9A, a sodium channel target. It has not been approved for any indication and remains in clinical development.

What is AZD3161 used for?

AZD3161 is being developed for peripheral neuropathic pain. It has also been studied in the context of nociceptive pain. The drug is investigational and has not been approved for any use. Its clinical evaluation has been limited to a Phase 1 trial in healthy volunteers.

What does AZD3161 target?

AZD3161 targets SCN9A, a sodium channel. It acts as a blocker of this target. SCN9A is associated with pain signaling, and blocking it is the intended mechanism for treating peripheral neuropathic pain. The drug is a small molecule developed by AstraZeneca.

Who is developing AZD3161?

AZD3161 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this investigational small molecule. The company is responsible for its development in peripheral neuropathic pain.

What phase is AZD3161 in?

AZD3161 is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials. The drug is investigational and has not been approved by the FDA or any regulatory agency for any indication.

What clinical trials is AZD3161 in?

AZD3161 has been studied in one completed Phase 1 trial, NCT01240148. The trial enrolled 26 healthy volunteers in the United Kingdom and evaluated the effect of AZD3161 injected intradermally on quantitative sensory testing variables in normal and ultraviolet-C exposed skin. It was randomized, double-blind, and placebo-controlled.