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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Results of mechanical pain testing using Quantitative Sensory Testing [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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

  • Clinical chemistry (urinalysis, hematology) [ Time Frame: At follow up (a range of 8-15 days after Day 1) ] [ Designated as safety issue: Yes ]
  • The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Nociceptive Pain
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms processed this record on May 30, 2016