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

NCT01538797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-02-24

No results posted yet for this study

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.

Conditions

  • Reflux Oesophagitis

Interventions

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.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Trio Medicines Ltd.

    lead INDUSTRY

Principal Investigators

  • Malcolm J Boyce, FRCP FFPM · Trio Medicines Limited

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
1996-07-31
Primary Completion
1996-08-31
Completion
1996-08-31

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 NCT01538797 on ClinicalTrials.gov