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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo solution
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.
干预措施: Placebo (Drug)
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.
干预措施: PPC-5650 (Drug)
结局指标
主要结局
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)
时间窗: 4 hours
次要结局
- Number of observed adverse effects (safety profile) and changes in size of referred pain area(1 month)
研究者
Asbjørn Mohr Drewes
Professor, MD, PhD
Aalborg University Hospital