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

Phase 1

Completed

• Conditions: Capsaicin Evoked Pain; Heat Sensitivity
• Interventions: Drug: AZD1386; Drug: Placebo

• Registration Number: NCT00692146
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Last Update Submitted: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Posted: 2008-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1386	36 subjects receiving a specified volume of the active component AZD1386 in a single dose.
2	Placebo	36 subjects receiving a specified volume of placebo in a single dose.

Primary Outcome Measures

Name	Time	Method
VAS, HPT	Visit 2-4

Secondary Outcome Measures

Name	Time	Method
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