Back to resultsOpen-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.
Primary Purpose
Gastroesophageal Reflux Disease, Reflux, Gastroesophageal
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Lavoltidine
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring pharmacodynamics,, tolerance, H2 antagonist,, AH23844,, lavoltidine,, gastroesophageal reflux disease (GERD), pharmacokinetics,
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Helicobacter-positive on a C13 urea breath test
- have a baseline median 24-hour gastric pH>3
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00551473
Brief Title
Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.
Official Title
An Open-Label Study of the Development of Pharmacodynamic Tolerance to 7-days Administration of Lavoltidine 40mg
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Reflux, Gastroesophageal
Keywords
pharmacodynamics,, tolerance, H2 antagonist,, AH23844,, lavoltidine,, gastroesophageal reflux disease (GERD), pharmacokinetics,
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lavoltidine
Primary Outcome Measure Information:
Title
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.
Time Frame
seven days
Secondary Outcome Measure Information:
Title
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.
Time Frame
seven days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Helicobacter-positive on a C13 urea breath test
have a baseline median 24-hour gastric pH>3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.
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