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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Capsaicin Evoked Pain; Heat Sensitivity

Treatments: Drug: Placebo; Drug: AZD1386

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692146

D5090C00009

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: AZD1386

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo