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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

Primary Purpose

Peripheral Neuropathic Pain, Nociceptive Pain

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD3161
Lidocaine
AZD3161 Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peripheral Neuropathic Pain focused on measuring Allodynia, hyperalgesia, paresthesia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

Arm Description

150 μL intradermal injection of 1 μmol/L AZD3161

150 μL intradermal injection of 6 μmol/L AZD3161

150 μL intradermal injection of 30 μmol/L AZD3161

150 μL intradermal injection of 10 mg/mL Lidocaine

150 μL intradermal injection of AZD3161 placebo

Outcomes

Primary Outcome Measures

Results of mechanical pain testing using Quantitative Sensory Testing

Secondary Outcome Measures

Number of participants with Adverse Events
Vital signs
(blood pressure, heart rate, pulse)
Clinical chemistry (urinalysis, hematology)
The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan

Full Information

First Posted
November 10, 2010
Last Updated
April 11, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01240148
Brief Title
Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain, Nociceptive Pain
Keywords
Allodynia, hyperalgesia, paresthesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
150 μL intradermal injection of 1 μmol/L AZD3161
Arm Title
2
Arm Type
Experimental
Arm Description
150 μL intradermal injection of 6 μmol/L AZD3161
Arm Title
3
Arm Type
Experimental
Arm Description
150 μL intradermal injection of 30 μmol/L AZD3161
Arm Title
4
Arm Type
Active Comparator
Arm Description
150 μL intradermal injection of 10 mg/mL Lidocaine
Arm Title
5
Arm Type
Placebo Comparator
Arm Description
150 μL intradermal injection of AZD3161 placebo
Intervention Type
Drug
Intervention Name(s)
AZD3161
Intervention Description
Single dose, intradermal injection
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Single dose, intradermal injection
Intervention Type
Drug
Intervention Name(s)
AZD3161 Placebo
Primary Outcome Measure Information:
Title
Results of mechanical pain testing using Quantitative Sensory Testing
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
Range of 14 days
Title
Vital signs
Description
(blood pressure, heart rate, pulse)
Time Frame
Day 1
Title
Clinical chemistry (urinalysis, hematology)
Time Frame
At follow up (a range of 8-15 days after Day 1)
Title
The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren Wilbraham, MD, MBBS DCPSA
Organizational Affiliation
Quintiles Drug Research Unit at Guy's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bo Fransson
Organizational Affiliation
AstraZeneca R&D
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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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