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

ONO-8539

Placebo

Area under the curve (AUC) of the change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.

Area under the Curve (AUC) of the change from baseline in pain threshold in the distal oesophagus following electrical stimulation after oesophageal acid infusion

Maximum change from baseline in pain threshold in the proximal and distal oesophagus following electrical stimulation after oesophageal acid infusion.

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.

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).

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.

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.

Safety and tolerability: adverse events, physical examination, body weight, vital signs, 12-lead Electrocardiogram (ECG) and safety laboratory evaluations.

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.