drugset / Trial / NCT01699113

Effects of YF476 and Rabeprazole on Gastric Function

NCT01699113

Phase 1 Completed 32 enrolled Trio Medicines Ltd.
RandomizedParallel-groupDouble-blindBasic science

Summary

The primary objectives are to find out in healthy subjects if: * YF476 prevents the ECL-cell hyperplasia induced by repeated doses of rabeprazole - a proton pump inhibitor; * YF476 also prevents rebound hyperacidity after stopping rabeprazole; and * YF476 by itself causes neither ECL-cell hyperplasia after repeated doses nor rebound hyperacidity after stopping YF476. The secondary objectives are to: * assess the safety and tolerability of YF476, alone and in combination with rabeprazole; * compare the effects of YF476, alone and in combination with rabeprazole, on serum gastrin and plasma CgA and SST; * assess if there is a pharmacokinetic interaction between YF476 and rabeprazole; * assess the pharmacokinetics of repeat doses of YF476 by itself; and * study the metabolism of YF476.

Timeline

Start
2006-08
Primary completion
2007-06
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabeprazole Small molecule 20 mg Oral
Subject netazepide Protein / enzyme biologic 100 mg Oral