Recent Updates
Recently added Catalysts

Lavoltidine

Phase 1

Gastroesophageal Reflux Disease | Small molecule | Gastrointestinal |GSK plc|Last Updated: Jun 4, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Lavoltidine · 1 trial · 2 indications

Phase 1 1
NCT00551473Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.Gastroesophageal Reflux Disease
COMPLETED18 Analytics
PHASE1COMPLETED
Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.
Gastroesophageal Reflux DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Interventions

NameTypeDescription
LavoltidineDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 p...

Countries:Australia
Unlock Eligibility Criteria

Frequently asked questions about Lavoltidine

What is Lavoltidine used for?

Lavoltidine is an investigational small molecule being studied for the treatment of Gastroesophageal Reflux Disease (GERD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its effect on gastric pH in patients with GERD.

Who makes Lavoltidine?

Lavoltidine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Gastroesophageal Reflux Disease.

What phase is Lavoltidine in?

Lavoltidine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for Gastroesophageal Reflux Disease.

What clinical trials is Lavoltidine in?

Lavoltidine has one completed Phase 1 clinical trial registered under NCT00551473. This open-label, uncontrolled study evaluated the effect of once-daily administration of Lavoltidine 40 mg on 24-hour gastric pH on days 1, 2, and 7 in 18 healthy male volunteers in Australia.

How does Lavoltidine work?

Lavoltidine is a small molecule developed for Gastroesophageal Reflux Disease. Its specific molecular target has not been disclosed in available information. The drug is being studied for its ability to affect gastric pH, which is relevant to managing acid reflux symptoms.