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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 10, 2010
Last updated: April 11, 2011
Last verified: April 2011
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.

Condition Intervention Phase
Peripheral Neuropathic Pain
Nociceptive Pain
Drug: AZD3161
Drug: Lidocaine
Drug: AZD3161 Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Results of mechanical pain testing using Quantitative Sensory Testing [ Time Frame: Day 1 ]

Secondary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: Range of 14 days ]
  • Vital signs [ Time Frame: Day 1 ]
    (blood pressure, heart rate, pulse)

  • Clinical chemistry (urinalysis, hematology) [ Time Frame: 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 [ Time Frame: Day 1 ]

Enrollment: 26
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01240148

United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Principal Investigator: Darren Wilbraham, MD, MBBS DCPSA Quintiles Drug Research Unit at Guy's Hospital
Study Chair: Bo Fransson AstraZeneca R&D
  More Information

Responsible Party: Medical Science Director, AstraZeneca Identifier: NCT01240148     History of Changes
Other Study ID Numbers: D3780C00005
Study First Received: November 10, 2010
Last Updated: April 11, 2011

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Nociceptive Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017