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

Condition(s) targeted: Capsaicin Evoked Pain; Heat Sensitivity

Intervention: AZD1386 (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Agneta Berg, Study Chair, Affiliation: AstraZeneca R&D Södertälje
Ingemar Bylesjö, Principal Investigator, Affiliation: AstraZeneca R&D CPU Karolinska University Hospital, Stockholm

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

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

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

Primary outcome: VAS, HPT

Secondary outcome:

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

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

Pharmacokinetics/Pharmacodynamics

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Starting date: January 2008
Last updated: June 5, 2008