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GSK598809, using --PHNO

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Oct 28, 2010

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00468806Study of Safety, Blood Levels and Brain Receptor Occupancy of GSK598809 Using PET Imaging in Health Males.PHASE1 COMPLETED 25 — — Apr 1, 2007May 1, 2008Oct 28, 20101 Canada
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Study Endpoints
Primary Endpoints
%D3 RO at Tmax
approx 1.5 hrs
Percentage occupancy at Tmax
approx 1.5 hrs
Ttrough
approx 24 hrs
time course of GSK598809 plasma concentration following a single oral dose of GSK598809
at predose,1,1.5,2,3,4,8,24 and 48 hrs.
Secondary Endpoints
Prolactin/TSH levels
at predose,1, 2, 4,8 & 24 hrs postdose
Akathisia
at baseline at 1, 4 hrs postdose
EPQ, BIS-BAS:
at screening
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
GSK598809, using [11C]-(+)-PHNODRUG -
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Eligibility Criteria
Age Range25 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy male subjects, defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests. * Aged 25-55 years inclusive, at screening visit. * Bo...

Countries:Canada
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