Nociceptive Pain, Peripheral Neuropathic Pain
Conditions
Keywords
Allodynia, hyperalgesia, paresthesia
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.
Interventions
DRUGAZD3161
Single dose, intradermal injection
DRUGLidocaine
Single dose, intradermal injection
DRUGAZD3161 Placebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Results of mechanical pain testing using Quantitative Sensory Testing | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed