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

June 5, 2008 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
36 subjects receiving a specified volume of the active component AZD1386 in a single dose.
Drug: AZD1386
Oral solution fixed dose (95 mg given orally on two occasions)
PLACEBO_COMPARATOR: 2
36 subjects receiving a specified volume of placebo in a single dose.
Drug: Placebo
Oral solution fixed dose (95 mg given orally on two occasions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS, HPT
Time Frame: Visit 2-4
Visit 2-4

Secondary Outcome Measures

Outcome Measure
Time Frame
eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia
Time Frame: Visit 2-4
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
Visit 1-5
Pharmacokinetics/Pharmacodynamics
Time Frame: Visit 2-4
Visit 2-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Agneta Berg, AstraZeneca R&D Södertälje
  • Principal Investigator: Ingemar Bylesjö, AstraZeneca R&D CPU Karolinska University Hospital, Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (ESTIMATE)

June 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2008

Last Update Submitted That Met QC Criteria

June 5, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5090C00009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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