Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

AstraZeneca36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Capsaicin Evoked Pain Heat Sensitivity

Interventions

AZD1386DRUG

Oral solution fixed dose (95 mg given orally on two occasions)

PlaceboDRUG

Oral solution fixed dose (95 mg given orally on two occasions)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

VAS, HPT

Time frame: Visit 2-4

Secondary Outcomes

eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia

Time frame: 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

Time frame: Visit 1-5

Pharmacokinetics/Pharmacodynamics

Time frame: Visit 2-4

Data from ClinicalTrials.gov

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