Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to investigate the effect of AZD3161 on mechanical pain sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.

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Detailed Description

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Conditions

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Peripheral Neuropathic Pain Nociceptive Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

150 μL intradermal injection of 1 μmol/L AZD3161

Group Type EXPERIMENTAL

AZD3161

Intervention Type DRUG

Single dose, intradermal injection

2

150 μL intradermal injection of 6 μmol/L AZD3161

Group Type EXPERIMENTAL

AZD3161

Intervention Type DRUG

Single dose, intradermal injection

3

150 μL intradermal injection of 30 μmol/L AZD3161

Group Type EXPERIMENTAL

AZD3161

Intervention Type DRUG

Single dose, intradermal injection

4

150 μL intradermal injection of 10 mg/mL Lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Single dose, intradermal injection

5

150 μL intradermal injection of AZD3161 placebo

Group Type PLACEBO_COMPARATOR

AZD3161 Placebo

Intervention Type DRUG

Interventions

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AZD3161

Single dose, intradermal injection

Intervention Type DRUG

Lidocaine

Single dose, intradermal injection

Intervention Type DRUG

AZD3161 Placebo

Intervention Type DRUG

Eligibility Criteria

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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, must not be lactating and must be of non-child-bearing potential
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh between 50 kg and 100 kg inclusive
* Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with investigational product.

Exclusion Criteria

* Presence of skin disorders, tattoos or other skin conditions that may interfere with the QST measurements, as judged by the Investigator
* Recent exposure to significant amount of UV light, as judged by the Investigator.
* Use of any prescribed or non-prescribed analgesics (including paracetamol/acetaminophen or drugs affecting blood flow (including nasal anticongestants), prior to the first administration of investigational product that may interfere with the study objectives.
* History of severe allergy/hypersensitivity, or ongoing allergy/hypersensitivity as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3161.
* Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes