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GSK1034702

Phase 1

Cognitive Disorders | Small molecule | Other |GSK plc|Last Updated: Jul 21, 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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00937846Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan StudyPHASE1 COMPLETED 4Jul 15, 2009Aug 28, 2009Jun 27, 20172 United Kingdom
NCT00743405Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy SubjectsPHASE1 COMPLETED 30May 2, 2008Dec 15, 2008Jul 21, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.
Scanning day
•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.
20 weeks
Secondary Endpoints
The kinetic rate constants at tracer and pharmacological doses.
Scanning day
GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).
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Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
2 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
GSK1034702EXPERIMENTALSingle oral 5 mg dose in liquid formulation
Cohort 1OTHERSubjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan
Cohort 2OTHERSubjects will be receive GSK1034702 5 mg following the dose escalation plan
Interventions
NameTypeDescription
GSK1034702DRUGSingle oral 5 mg dose in liquid formulation
PlaceboDRUGTo match GSK1034702
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Eligibility Criteria
Age Range35 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Generally healthy. * Male between 35 and 55 years of age. * Willing to use appropriate contraception method. * Weight more than 50 kg. * BMI within the range 19 - 29 kg/m2. * Adequate blood supply to the hand. Exclusion Criteria: * Abuse of drugs or alcohol. * Smoker or hist...

Countries:United Kingdom
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Competitive Landscape -Cognitive Disorders 9 trials
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