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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00692146
First received: June 5, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Capsaicin Evoked Pain
Heat Sensitivity
Drug: AZD1386
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • VAS, HPT [ Time Frame: Visit 2-4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia [ Time Frame: Visit 2-4 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics/Pharmacodynamics [ Time Frame: Visit 2-4 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692146

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Agneta Berg AstraZeneca R&D Södertälje
Principal Investigator: Ingemar Bylesjö AstraZeneca R&D CPU Karolinska University Hospital, Stockholm
  More Information

No publications provided

Responsible Party: Rolf Karlsten, MD, PhD Medical Science Director, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier: NCT00692146     History of Changes
Other Study ID Numbers: D5090C00009
Study First Received: June 5, 2008
Last Updated: June 5, 2008
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Proof of Mechanism
Capsaicin evoked pain

Additional relevant MeSH terms:
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014