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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01240148
First received: November 10, 2010
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov 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:
Allodynia
hyperalgesia
paresthesia

Additional relevant MeSH terms:
Neuralgia
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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013