Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)
Phase 1
Completed
- Conditions
- Capsaicin Evoked PainHeat Sensitivity
- Interventions
- Drug: AZD1386Drug: 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
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
Read More
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.
Read More
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