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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Nociceptive Pain; Peripheral Neuropathic Pain

Treatments: Drug: AZD3161 Placebo; Drug: Lidocaine; Drug: AZD3161

Study type: Interventional

Funder types: Industry

Identifiers

NCT01240148

D3780C00005

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

26 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

150 μL intradermal injection of 1 μmol/L AZD3161

Treatment:

Drug: AZD3161

2

Experimental group

Description:

150 μL intradermal injection of 6 μmol/L AZD3161

Treatment:

Drug: AZD3161

3

Experimental group

Description:

150 μL intradermal injection of 30 μmol/L AZD3161

Treatment:

Drug: AZD3161

4

Active Comparator group

Description:

150 μL intradermal injection of 10 mg/mL Lidocaine

Treatment:

Drug: Lidocaine

5

Placebo Comparator group

Description:

150 μL intradermal injection of AZD3161 placebo

Treatment:

Drug: AZD3161 Placebo