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

Phase 1

Completed

• Conditions: Gastroesophageal Reflux; Gastroesophageal Reflux Disease
• Interventions: Drug: Placebo; Drug: PPC-5650

• Registration Number: NCT01818570
• Lead Sponsor: Asbjørn Mohr Drewes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-26
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo solution	Placebo	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.
PPC-5650	PPC-5650	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.

Primary Outcome Measures

Name	Time	Method
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)	4 hours

Secondary Outcome Measures

Name	Time	Method
Number of observed adverse effects (safety profile) and changes in size of referred pain area	1 month

Trial Locations

Locations (1)

Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital; 🇩🇰 Aalborg, Jutland, Denmark