NCT00551473

Brief Summary

Current treatment for gastroesophageal reflux disease(GERD)confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric acid suppression. Clinical data on lavoltidine demonstrates a rapid onset of action, high potency, and prolonged duration of effect after single dose. Since tolerance to the class of compounds to which lavoltidine belongs may be dose dependent, the current study is designed to determine if 40mg lavoltdine given for 7days develops tolerance.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
Last Updated

June 4, 2012

Status Verified

February 1, 2011

First QC Date

October 29, 2007

Last Update Submit

May 31, 2012

Conditions

Gastroesophageal Reflux DiseaseReflux, Gastroesophageal

Keywords

pharmacodynamics,toleranceH2 antagonist,AH23844,lavoltidine,gastroesophageal reflux disease (GERD), pharmacokinetics,

Outcome Measures

Primary Outcomes (1)

  • To determine the degree of pharmacodynamic tolerance following seven days administration of lavoltidine 40mg on gastric pH as assessed by percentage of 24hrs pH>4.

    seven days

Secondary Outcomes (1)

  • To determine whether or not significant pharmacodynamic tolerance occurs as early as the second dose of 40mg lavoltidine. Safety and tolerance of seven days administration of lavoltidine 40 mg, in healthy male volunteers.

    seven days

Interventions

LavoltidineDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male, from 18-55 years
  • Have BMI from 19-30 kg/m2
  • do not present with abnormal clinical lab findings
  • are able to tolerate a nasogastric pH electrode.

You may not qualify if:

  • Helicobacter-positive on a C13 urea breath test
  • have a baseline median 24-hour gastric pH\>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 31, 2007

Study Start

May 1, 2007

Last Updated

June 4, 2012

Record last verified: 2011-02

Locations

AU(1)