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GSK206136

Phase 1

Depressive Disorder and Anxiety Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Aug 10, 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 Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01059578First Study in Humans With GSK206136PHASE1 COMPLETED 33May 23, 2006Dec 18, 2006Aug 10, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2
12 weeks
Secondary Endpoints
Brain receptor occupancy
2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALGSK206136 once daily
PlaceboPLACEBO_COMPARATORPlacebo once daily
Interventions
NameTypeDescription
GSK206136DRUGGSK206136 2mg, 10mg, 50mg, 100mg capsule
PLACEBODRUGPlacebo to match 206136 2mg, 10mg, 50mg, 100mg capsule
PETRADIATIONEach subject will undergo 3 PET Scans ; one at Baseline and the others following dosing with GSK206136 at approximately 2 hours post-dose and 24 hours post-dose
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 18-45 years, limited to 25-40 years of age for PET section Exclusion Criteria: * The subject has a positive: drug/alcohol, Hepatitis, HIV screen.. * The subject has a history of psychiatric illness suicidal attempts or behaviour. * Abuse of alcohol. * Clin...

Countries:United Kingdom
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