Esophageal Sensitivity, Pain
Conditions
Keywords
GERD, healthy volunteer, esophagus, pain
Brief summary
The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli
Interventions
DRUGAZD1386
oral, single dose
DRUGPlacebo
Oral solution, single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of written consent * Clinically normal physical findings * Sensitization potential
Exclusion criteria
* Clinically significant illness within 2 weeks prior to the first dose of investigational product * History of clinically significant disease * Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS scale and clock | Several occasions during the study days |
Secondary
| Measure | Time frame |
|---|---|
| VAS scale and pressure, VAS scale and current, VAS scale and acid volume | Several occasions during the study days |
| Pharmacokinetic variables | Several occasions during the study days |
| Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature) | Several occasions during the study days |
Countries
Denmark, Sweden
Outcome results
None listed