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

NCT01240148 | Completed Phase 1

• 1 other identifier: D3780C00005
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathic Pain; Nociceptive Pain

Keywords

Allodynia; hyperalgesia; paresthesia

Outcome Measures

Primary Outcomes (1)

• Results of mechanical pain testing using Quantitative Sensory Testing

  Day 1

Secondary Outcomes (4)

• Number of participants with Adverse Events

  Range of 14 days

• Vital signs

  Day 1

• 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

Study Arms (5)

1

EXPERIMENTAL

150 μL intradermal injection of 1 μmol/L AZD3161

Drug: AZD3161

2

EXPERIMENTAL

150 μL intradermal injection of 6 μmol/L AZD3161

Drug: AZD3161

3

EXPERIMENTAL

150 μL intradermal injection of 30 μmol/L AZD3161

Drug: AZD3161

4

ACTIVE COMPARATOR

150 μL intradermal injection of 10 mg/mL Lidocaine

Drug: Lidocaine

5

PLACEBO COMPARATOR

150 μL intradermal injection of AZD3161 placebo

Drug: AZD3161 Placebo

Interventions

AZD3161 DRUG

Single dose, intradermal injection

1; 2; 3

Lidocaine DRUG

Single dose, intradermal injection

4

AZD3161 Placebo DRUG

5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Nociceptive Pain; Hyperalgesia; Paresthesia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Darren Wilbraham, MD, MBBS DCPSA

  Quintiles Drug Research Unit at Guy's Hospital

  PRINCIPAL INVESTIGATOR

• Bo Fransson

  AstraZeneca R&D

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 15, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 12, 2011

Record last verified: 2011-04

Locations

GB (1)