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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00551473
Other study ID # LAV110285
Secondary ID
Status Completed
Phase Phase 1
First received October 29, 2007
Last updated May 31, 2012
Start date May 2007

Study information

Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Drug:
Lavoltidine


Locations

Country Name City State
Australia GSK Investigational Site Randwick, Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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