Gastroesophageal Reflux Disease, Reflux, Gastroesophageal
Conditions
Keywords
tolerance, pharmacodynamics, ranitidine, esomeprazole, pharmacokinetics, gastroesophageal reflux disease (GERD), AH23844
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 AH234844 demonstrates a rapid onset of action, high potency, and prolonged duration of effect. The present study endeavors, in part, to compare lavoltidine to two GERD drugs, NEXIUM and ranitidine.
Detailed description
A three-part study in healthy male volunteers to determine the most effective of four different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM (esomeprazole) 40mg for the inhibition of gastric-acid secretion and with ranitidine (300mg/day) for the amount of pharmacodynamic tolerance
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must have a Body Mass Index (BMI) from 19-30 kg/m2 * Subject does not present with abnormal clinical lab findings * Subject is able to tolerate a nasogastric pH electrode.
Exclusion criteria
* Subject is Helicobacter-positive on a C13 urea breath test * Subject has a baseline median 24-hour gastric pH\>3 * For Part B of the study, subjects are CYP 2C19 poor metabolizers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pH over 24hours | over 24hours |
Secondary
| Measure | Time frame |
|---|---|
| %24 hours pH>4 Median gastric pH Adverse events | over 24 hours |
Countries
Australia
Outcome results
None listed