Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.
Phase 1
Completed
- Conditions
- Gastroesophageal Reflux DiseaseReflux, Gastroesophageal
- Registration Number
- NCT00551473
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Randwick, Sydney, New South Wales, Australia