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GSK945237

Phase 1

Healthy Subjects | Small molecule | Infectious Disease |GSK plc|Last Updated: Mar 19, 2012

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
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00517673To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy SubjectsPHASE1 COMPLETED 68Jul 1, 2007Sep 1, 2008Mar 19, 20121 Australia
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Study Endpoints
Primary Endpoints
Safety and tolerability
Day 1 to follow-up visit
Secondary Endpoints
Pharmacokinetics
Day 1 to Day 5
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
GSK945237EXPERIMENTALActive Study Drug
Sugar PillPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
GSK945237DRUG -
Sugar PillDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female adults between 18 and 60 years of age. * Body weight proportional to height. * Female subjects must be of non-childbearing potential. * QTc less than 450 msec at screening Exclusion Criteria: * Any clinically relevant abnormality identified on the scr...

Countries:Australia
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