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GI267119

Phase 1

Mental Disorders | Small molecule | Other |GSK plc|Last Updated: Sep 12, 2017

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00410371Study to Compare Two Formulations of Lamotrigine in Healthy SubjectsPHASE1 COMPLETED 96Dec 28, 2006Jan 25, 2007Sep 12, 20171 United States
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Study Endpoints
Primary Endpoints
Lamotrigine AUC(0-inf) and Cmax
Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Secondary Endpoints
tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points
throughout study
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GI267119EXPERIMENTAL25 mg ODT tablet strength
Interventions
NameTypeDescription
LamotrigineDRUGLamotrigine
GI267119DRUG25 mg ODT
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive. Exclusion Criteria: * Female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contracepti...

Countries:United States
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Competitive Landscape -Mental Health Disorders 11 trials
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