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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

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ClinicalTrials.gov Identifier: NCT01240148
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Neuropathic Pain Nociceptive Pain Drug: AZD3161 Drug: Lidocaine Drug: AZD3161 Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (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
Study Start Date : December 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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



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

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

  3. Clinical chemistry (urinalysis, hematology) [ Time Frame: At follow up (a range of 8-15 days after Day 1) ]
  4. The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan [ Time Frame: Day 1 ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240148


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

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01240148     History of Changes
Other Study ID Numbers: D3780C00005
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Keywords provided by AstraZeneca:
Allodynia
hyperalgesia
paresthesia

Additional relevant MeSH terms:
Neuralgia
Nociceptive Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
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