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Lavoltidine

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00551473Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.PHASE1 COMPLETED 18 — — May 1, 2007 -Jun 4, 20121 Australia
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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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
LavoltidineDRUG -
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Eligibility Criteria
Age Range18 Years — 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
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