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

A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Determine the Effect of Intradermal AZD3161 on Quantitative Sensory Testing Variables in Normal and UVC Exposed Skin in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Nociceptive Pain; Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: AZD3161; Drug: Lidocaine; Drug: AZD3161 Placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 150 μL intradermal injection of 1 μmol/L AZD3161	Drug: AZD3161; Single dose, intradermal injection
Experimental: 2; 150 μL intradermal injection of 6 μmol/L AZD3161	Drug: AZD3161; Single dose, intradermal injection
Experimental: 3; 150 μL intradermal injection of 30 μmol/L AZD3161	Drug: AZD3161; Single dose, intradermal injection
Active Comparator: 4; 150 μL intradermal injection of 10 mg/mL Lidocaine	Drug: Lidocaine; Single dose, intradermal injection
Placebo Comparator: 5; 150 μL intradermal injection of AZD3161 placebo	Drug: AZD3161 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Results of mechanical pain testing using Quantitative Sensory Testing	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events		Range of 14 days
Vital signs	(blood pressure, heart rate, pulse)	Day 1
Clinical chemistry (urinalysis, hematology)		At follow up (a range of 8-15 days after Day 1)
The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan		Day 1

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Darren Wilbraham, MD, MBBS DCPSA, Quintiles Drug Research Unit at Guy's Hospital; Study Chair: Bo Fransson, AstraZeneca R&D

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: November 10, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (Estimate): November 15, 2010

Study Record Updates

• Last Update Posted (Estimate): April 12, 2011
• Last Update Submitted That Met QC Criteria: April 11, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: hyperalgesia; paresthesia; Allodynia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Nociceptive Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: D3780C00005