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Safety, Tolerability and Pharmacokinetics of Single Rising Doses of YF476, a Gastrin Antagonist, in Healthy Men

NCT01538784 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-02-24

No results posted yet for this study

Summary

The objectives of the study were:

* To assess the safety, tolerability and pharmacokinetics of YF476 in healthy volunteers.
* To select a dose or doses of YF476 for detailed pharmacodynamic studies in healthy volunteers.

Conditions

  • Reflux Oesophagitis

Interventions

DRUG

YF476

Two groups of six subjects received single rising oral doses of YF476 capsules or matching placebo. Each subject received 2 doses of YF476 and 1 dose of placebo. 4 subjects received active and 2 placebo at each dose level, as follows: Group A YF476 0.5, 25 and 100mg by mouth Group B YF476 5.0, 50 and 100mg by mouth Groups A \& B were dosed alternately, at weekly intervals

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
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1996-05-31
Primary Completion
1996-06-30
Completion
1996-06-30

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 NCT01538784 on ClinicalTrials.gov