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GSK424887

Phase 1

Depressive Disorder and Anxiety Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Aug 11, 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_CONTROLLED
Total Trials2
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01424384Emotional Processing in Healthy Volunteers in the Presence of an Investigational AnxiolyticPHASE1 COMPLETED 54Sep 19, 2008Apr 30, 2009Jul 7, 20171 United Kingdom
NCT01059591First Study in Humans With GSK424887PHASE1 COMPLETED 26May 25, 2006Jan 25, 2007Aug 11, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Multiple emotional and psychometric battery of tests
< 1 day
Adverse Events, laboratory values, vital signs, ECGs
< 1 day
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax
12 weeks
Secondary Endpoints
Brain receptor occupancy
2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CitalopramACTIVE_COMPARATORMarketed comparitor
Investigational Medicinal ProductEXPERIMENTALGSK424887
Placebo To Match TreatmentPLACEBO_COMPARATORPlacebo control
ActiveEXPERIMENTALGSK424887 once daily
PlaceboPLACEBO_COMPARATORPlacebo once daily
Interventions
NameTypeDescription
CitalopramDRUGNeurophysiological testing.
GSK424887DRUGNeurophysiological testing
Plactebo To MatchDRUGNeurophysiological testing
PlaceboDRUGPlacebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule
PETRADIATIONEach subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males with no neurological, or history of psychiatric illness 2. Aged between 18 and 45 years 3. Agree to use contraception 4. BMI range of 18 to 33 kg/m² 5. Fluent English speakers 6. Non smoker or light smoker Exclusion Criteria: 1. Positive pre-study drug/alcohol...

Countries:United Kingdom
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