NCT01538797

Effect of Single Doses of YF476 on Stomach Acidity Compared With Ranitidine and Placebo in Fasted and Fed States

YF476: Effects of a Single Dose at 3 Dose Levels on 24-hour Ambulatory Gastric pH Compared With Placebo and Ranitidine in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Trio Medicines Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objectives of the study were: * To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect to their effects on basal- and food- stimulated gastric pH in healthy volunteers. * To assess whether there is a relationship between the pharmacokinetics of YF476 and gastric pH in healthy volunteers. * To assess the safety and tolerability of single doses of YF476 in healthy volunteers.

Detailed description

YF476 is clearly a potent and selective gastrin/CCK-B antagonist and should inhibit basal and meal-stimulated gastric acid secretion and enhance gastric emptying of a liquid meal in man. Therefore YF476 might benefit patients with reflux oesophagitis. The compound has been well tolerated in animal toxicity studies at doses in excess of the projected therapeutic dose in patients, and merits studies in healthy volunteers. Extrapolation from data obtained in animals suggests that a single oral dose of about 10mg of YF476 should compare favourably with an oral dose of 150mg of ranitidine in man with respect to effect on basal and food-stimulated gastric acid secretion. Therefore in the proposed study a range of doses of YF476 encompassing that dose will be studied; the exact dose of YF476 will be chosen on the basis of the previous study but the top dose will not exceed 100mg. 24-hour ambulatory gastric pH will be monitored via an intragastric pH electrode (7-10). Although there is variability between subjects with respect to the effects of food and drug treatment on gastric pH, the methodology for measurement of ambulatory gastric pH is robust.

Conditions

• Reflux Oesophagitis

Interventions

Type	Name	Description
DRUG	YF476	There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100 mg), placebo and ranitidine 150 mg. There were at least 7 days between consecutive Treatment Days.
DRUG	Ranitidine	There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100mg), placebo and ranitidine 150mg. There were at least 7 days between consecutive Treatment Days.

Timeline

• Start date: 1996-07-01
• Primary completion: 1996-08-01
• Completion: 1996-08-01
• First posted: 2012-02-24
• Last updated: 2012-02-24

Locations

1 site across 1 country: United Kingdom