Esophageal Hypersensitivity Study in Healthy Volunteers

AstraZeneca45 enrolled

Overview

The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Pain Esophageal Sensitivity

Interventions

AZD1386DRUG

oral, single dose

PlaceboDRUG

Oral solution, single dose

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Aarhus, Denmark

Research Site

Gothenburg, Sweden

Outcomes

Primary Outcomes

VAS scale and clock

Time frame: Several occasions during the study days

Secondary Outcomes

VAS scale and pressure, VAS scale and current, VAS scale and acid volume

Time frame: Several occasions during the study days

Pharmacokinetic variables

Time frame: Several occasions during the study days

Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)

Time frame: Several occasions during the study days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.