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

Asbjørn Mohr Drewes

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease; Gastroesophageal Reflux

Treatments: Drug: PPC-5650; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01818570

AROS-002

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Placebo solution

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

PPC-5650

Active Comparator group

Description:

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.

Treatment:

Drug: PPC-5650