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Drug

Phase 1

Mental Disorders | Small molecule | Other |GSK plc|Last Updated: Jun 14, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01371799A Study to Examine the Pharmacodynamic Effects of GSK1034702 on Neurophysiological Biomarkers of Cognition in Nicotine Abstained Otherwise Healthy SmokersPHASE1 COMPLETED 9Dec 17, 2009Jun 18, 2010Jun 14, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Measures will include changes in cognition measures of specific biomarkers
12 months

To investigate the effects of GSK1034702 on the mismatch negativity neurophysiologic marker of cognition.

Secondary Endpoints
Measures will include changes in the neurophysiologic markers of cognition
12 Months
Measures of changes in cognition biomarkers vs. the stduy drug
12 months
Measures of cogstate tests of attention in tests mentioned To investigate the effects of GSK1034702 on Cogstate neuropsychologic tests of attention, working memory, learning and executive function
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Study drug at 4mgEXPERIMENTALGSK1034702 at 4mg
Study drug at 8mgEXPERIMENTALGSK1034702 at 8mg
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
DrugDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Otherwise healthy smokers as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, psychiatric hi...

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