A Double-Blind, Randomized, Single-Centre, Placebo-Controlled, Crossover Study to Investigate the Effects of a Single Oral Dose of AZD1386 on Intradermal Capsaicin Evoked Pain Symptoms and Heat Sensitivity in Healthy Volunteers

AstraZeneca0 sites36 target enrollmentJanuary 2008

ConditionsCapsaicin Evoked Pain Heat Sensitivity

InterventionsAZD1386 Placebo

DrugsAZD1386 Placebo

Overview

Phase: Phase 1
Intervention: AZD1386
Conditions: Capsaicin Evoked Pain
Sponsor: AstraZeneca
Enrollment: 36
Primary Endpoint: VAS, HPT
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

May 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
•Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
•Non-fertile females

Exclusion Criteria

•History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
•History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Arms & Interventions

1

36 subjects receiving a specified volume of the active component AZD1386 in a single dose.

Intervention: AZD1386

2

36 subjects receiving a specified volume of placebo in a single dose.

Intervention: Placebo

Outcomes

Primary Outcomes

VAS, HPT

Time Frame: Visit 2-4

Secondary Outcomes

eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia(Visit 2-4)
Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3(Visit 1-5)
Pharmacokinetics/Pharmacodynamics(Visit 2-4)