A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acid Reflux

Treatments: Drug: ONO-8539; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01705275

ONO-8539POE012

Details and patient eligibility

About

A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy male adult volunteers.

Full description

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Caucasian male subjects, aged 18-45 years inclusive, will be entered into this study.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

ONO-8539 BID

Experimental group

Description:

ONO-8539

Treatment:

Drug: ONO-8539

Placebo BID

Placebo Comparator group

Description:

0mg

Treatment:

Other: Placebo