Reflux Oesophagitis Clinical Trial
Official title:
YF476: Effects of Repeated Dosing at 2 Dose Levels on 24-hour Ambulatory Gastric pH Compared With Placebo and Omeprazole in Healthy Volunteers
The objectives of this study were:
To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to
their effect on basal- and food- stimulated gastric pH in healthy volunteers.
To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to
their effect on basal and meal stimulated pH.
To assess the safety, tolerability and pharmacokinetics of repeated doses of YF476 in
healthy volunteers.
YF476 is clearly a potent and selective gastrin/CCK-B antagonist and should inhibit basal
and meal-stimulated gastric acid secretion, enhance gastric emptying of a liquid meal and
increase lower oesphageal sphincter pressure in man. Therefore YF476 might benefit patients
with reflux oesophagitis.
YF476 has been well tolerated in healthy volunteers at single doses up to 100mg and
remarkably well tolerated at repeat doses in animals up to 350 times the maximum dose
planned for the proposed study. A range of doses of YF476 (25 and 100mg twice daily) will be
administered to steady state. 24-hour ambulatory gastric pH will be monitored via an
intragastric pH electrode to assess the effect of YF476 on basal and meal stimulated gastric
pH. 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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01538784 -
Safety, Tolerability and Pharmacokinetics of Single Rising Doses of YF476, a Gastrin Antagonist, in Healthy Men
|
Phase 1 | |
| Completed |
NCT01538797 -
Effect of Single Doses of YF476 on Stomach Acidity Compared With Ranitidine and Placebo in Fasted and Fed States
|
Phase 1 | |
| Completed |
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Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers
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Phase 1 |