Capsaicin Evoked Pain, Heat Sensitivity
Conditions
Keywords
Proof of Mechanism, Capsaicin evoked pain
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
Interventions
DRUGAZD1386
Oral solution fixed dose (95 mg given orally on two occasions)
DRUGPlacebo
Oral solution fixed dose (95 mg given orally on two occasions)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS, HPT | Visit 2-4 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed