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

Phase 1

Completed

• Conditions: Peripheral Neuropathic Pain; Nociceptive Pain
• Interventions: Drug: AZD3161; Drug: AZD3161 Placebo; Drug: Lidocaine

• Registration Number: NCT01240148
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-15
• Study Start: 2010-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD3161	150 μL intradermal injection of 1 μmol/L AZD3161
2	AZD3161	150 μL intradermal injection of 6 μmol/L AZD3161
3	AZD3161	150 μL intradermal injection of 30 μmol/L AZD3161
5	AZD3161 Placebo	150 μL intradermal injection of AZD3161 placebo
4	Lidocaine	150 μL intradermal injection of 10 mg/mL Lidocaine

Primary Outcome Measures

Name	Time	Method
Results of mechanical pain testing using Quantitative Sensory Testing	Day 1

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	Range of 14 days
Vital signs	Day 1	(blood pressure, heart rate, pulse)
Clinical chemistry (urinalysis, hematology)	At follow up (a range of 8-15 days after Day 1)
The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan	Day 1

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom