Clinical trial NCT01240148: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Neuropathic Pain
Nociceptive Pain
Keywords: Allodynia
hyperalgesia
paresthesia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Results of mechanical pain testing using Quantitative Sensory Testing
timeFrame: Day 1
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: Range of 14 days
measure: Vital signs
timeFrame: Day 1
measure: Clinical chemistry (urinalysis, hematology)
timeFrame: At follow up (a range of 8-15 days after Day 1)
measure: The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan
timeFrame: Day 1
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Darren Wilbraham, MD, MBBS DCPSA
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D
name: Bo Fransson
role: STUDY_CHAIR
References: