A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus

Study Overview
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Brief Summary
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The purpose of this trial is to evaluate the effect of a single PPC-5650 dose in a human pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the esophagus.

Official Title
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A Single-center, Randomized, Double-blind, Cross-over Trial in Healthy Volunteers Investigating the Local Efficacy and Safety of a Single Intra-luminal Administration of PPC-5650 on Reflux Pain and Hyperalgesia During Multimodal Stimulation of the Esophagus

Conditions
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Gastroesophageal Reflux, Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: PPC-5650
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent before any study specific procedures Able to read and understand Danish. Healthy i.e. no history of chronic or recurrent pain rewarding diseases Able to co-operate and tolerate the experimental procedures (as assessed in the training visit) No over the counter medication 24h before the three visits No medications in the study period BMI 18.5-35.0 Caucasian No symptoms of Gastroesophageal reflux disease All men must use a safe method of contraception during the study period Exclusion Criteria: Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, and/or urine analyses, as judged by the investigator. Participation in any other clinical trial within three months prior to the training day. Alcohol or drug abuse. Mental illnesses Allergic to the active ingredient in the investigational medicinal product

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo solution<br>A 100 ml placebo solution will be administered through an esophageal probe. 100 ml will be administered as an infusion with a rate of 7ml/min. Healthy volunteers will be treated with placebo in one out of three visit days. | Drug: Placebo<br>* A 100 ml placebo solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.<br>|
| Active Comparator: PPC-5650<br>PPC-5650 is a asic-sensing ion channel-1a antagonist that can block the acid-sensing ion channels, leading to a reduction in the pain signal under up-regulated conditions. A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered through an esophageal probe to assess local effects. 100 ml will be administered as an infusion with a rate of 7ml/min. Healthy volunteers will be treated with PPC-5650 in one out of three visit days. | Drug: PPC-5650<br>* A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical) |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of observed adverse effects (safety profile) and changes in size of referred pain area |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux