Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Reflux, Gastroesophageal; Gastroesophageal Reflux Disease

Treatments: Drug: Lavoltidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551473

LAV110285

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)