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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asbjørn Mohr Drewes
• Treatments: Pharmaceutical Solutions

Criteria

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