Gastroesophageal Reflux Disease, Reflux, Gastroesophageal
Conditions
Keywords
pharmacodynamics,, tolerance, H2 antagonist,, AH23844,, lavoltidine,, gastroesophageal reflux disease (GERD), pharmacokinetics,
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.
Interventions
DRUGLavoltidine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia
Outcome results
None listed