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Effects of YF476 and Rabeprazole on Gastric Function

NCT01699113 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-10-03

No results posted yet for this study

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.

Conditions

  • Hypergastrinaemia

Interventions

DRUG

YF476

Subjects will be randomised to once daily treatment by mouth for 6 weeks with: * YF476 100 mg; or * rabeprazole 20 mg; or * a combination of YF476 100 mg and rabeprazole 20 mg.

DRUG

Rabeprazole

Subjects will be randomised to once daily treatment by mouth for 6 weeks with: * YF476 100 mg; or * rabeprazole 20 mg; or * a combination of YF476 100 mg and rabeprazole 20 mg.

Sponsors & Collaborators

  • Trio Medicines Ltd.

    lead INDUSTRY

Principal Investigators

  • Malcolm Boyce · Trio Medicines Limited

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01699113 on ClinicalTrials.gov