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SB-659032

Phase 1

Atherosclerosis | Small molecule | Cardiovascular |GSK plc|Last Updated: Dec 17, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01745458SB-659032 Platelet Aggregation StudyPHASE1 COMPLETED 26Jul 1, 2005Dec 1, 2005Dec 10, 20121 Australia
NCT01750827A Study to Assess the Effect of SB 659032 on Platelet FunctionPHASE1 COMPLETED 14Sep 1, 2004Nov 1, 2004Dec 17, 20121 United States
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Study Endpoints
Primary Endpoints
Platelet aggregation
14 days

Percent maximum platelet aggregation following ADP- and collagen-induced aggregation

Biomarkers of platelet aggregation
14 days

Urinary 11-dehydrothromboxane B2 and blood CD62 concentrations

Secondary Endpoints
Lp-PLA2 inhibition
14 days
Clinical safety data
14 days
Mean concentrations of SB-659032 and its major metabolite, SB-664601
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SB-659032EXPERIMENTAL250 mg non-enteric coated SB-659032
PlaceboPLACEBO_COMPARATORmatched placebo QD for 14 days
Interventions
NameTypeDescription
SB-659032DRUG -
PlaceboDRUGMatched placebo
SB659032DRUGsingle dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult males between 18 and 55 years of age, inclusive * Body weight greater than 50 kg (110 pounds) and body mass index (BMI) between 19 and 32 where: BMI = weight in kg/(height in meters)2 * A signed and dated written informed consent prior to admission to the study *...

Countries:AustraliaUnited States
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