Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01240148
NCT01240148CompletedPhase 1

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

AstraZeneca1 site in 1 country26 target enrollmentStarted: December 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Results of mechanical pain testing using Quantitative Sensory Testing
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts 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 AZD
  • •Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening

Arms & Interventions

1

Experimental

150 μL intradermal injection of 1 μmol/L AZD3161

Intervention: AZD3161 (Drug)

2

Experimental

150 μL intradermal injection of 6 μmol/L AZD3161

Intervention: AZD3161 (Drug)

3

Experimental

150 μL intradermal injection of 30 μmol/L AZD3161

Intervention: AZD3161 (Drug)

4

Active Comparator

150 μL intradermal injection of 10 mg/mL Lidocaine

Intervention: Lidocaine (Drug)

5

Placebo Comparator

150 μL intradermal injection of AZD3161 placebo

Intervention: AZD3161 Placebo (Drug)

Outcomes

Primary Outcomes

Results of mechanical pain testing using Quantitative Sensory Testing

Time Frame: Day 1

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Phase 2
Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the KneePain
NCT00878501AstraZeneca241
Terminated
Phase 2
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic PainPainNeuropathic Pain
NCT00976534AstraZeneca90
Completed
Phase 2
Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic NeuropathyPainDiabetic Neuropathy
NCT00857623AstraZeneca127
Completed
Phase 2
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386Pain
NCT00672646AstraZeneca103
Completed
Phase 2
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940Pain
NCT00659490AstraZeneca151