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

Nociceptive Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240148
• Other study ID #: D3780C00005
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2010
• Last updated: April 11, 2011
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neuralgia
• Nociceptive Pain
• Peripheral Neuropathic Pain

Intervention

Drug:
• AZD3161
Single dose, intradermal injection
• Lidocaine
Single dose, intradermal injection
• AZD3161 Placebo

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of mechanical pain testing using Quantitative Sensory Testing		Day 1	No
Secondary	Number of participants with Adverse Events		Range of 14 days	Yes
Secondary	Vital signs	(blood pressure, heart rate, pulse)	Day 1	Yes
Secondary	Clinical chemistry (urinalysis, hematology)		At follow up (a range of 8-15 days after Day 1)	Yes
Secondary	The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan		Day 1	No