NCT01705275已完成1 期
A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Acid-induced Oesophageal Hypersensitivity in Healthy Male Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) of the change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.
研究概览
简要总结
A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers.
详细描述
This is a randomised, double-blind, placebo-controlled, two-period crossover study, to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers. Each subject will be randomised to ONO-8539 or placebo twice daily in the first treatment period and the alternate treatment in the second treatment period. Dosing in each period will be for 15 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasian male subjects, aged 18-45 years inclusive, will be entered into this study.
排除标准
- •Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results.
研究组 & 干预措施
ONO-8539 BID
Experimental
ONO-8539
干预措施: ONO-8539 (Drug)
Placebo BID
Placebo Comparator
0mg
干预措施: Placebo (Other)
结局指标
主要结局
Area under the curve (AUC) of the change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.
时间窗: 15 days
次要结局
- Area under the Curve (AUC) of the change from baseline in pain threshold in the distal oesophagus following electrical stimulation after oesophageal acid infusion(15 days)
- Maximum change from baseline in pain threshold in the proximal and distal oesophagus following electrical stimulation after oesophageal acid infusion.(15 days)
- Change in absolute pain threshold from baseline in the proximal and distal oesophagus and somatic control following electrical stimulation after oesophageal acid infusion at each time point.(15 Days)
- Change from baseline at each time point in subject reported pain following electrical stimulation after oesophageal acid infusion using the short-form McGill pain questionnaire (SF-MPQ).(15 Days)
- Relationship between the pharmacokinetics of ONO-8539 and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.(15 Days)
- Relationship between State Trait Anxiety Inventory (STAI)-state score and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.(15 Days)
- Safety and tolerability: adverse events, physical examination, body weight, vital signs, 12-lead Electrocardiogram (ECG) and safety laboratory evaluations.(15 Days)
- The maximum observed plasma concentrations (Cmax), time to reach Cmax (Tmax), area under the curve (AUC), and trough concentration of ONO-8539 prior to dosing.(15 Days)
研究者
研究点 (1)
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