Status:
COMPLETED
Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Conditions:
Peripheral Neuropathic Pain
Nociceptive Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01240148
Start Date
December 1 2010
End Date
March 1 2011
Last Update
April 12 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
London, United Kingdom