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SB-659032

Phase 1

Atherosclerosis | Small molecule | Cardiovascular |GSK plc|Last Updated: Dec 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

SB-659032 · 2 trials · 1 indication

Phase 1 2
NCT01745458SB-659032 Platelet Aggregation StudyAtherosclerosis
COMPLETED26 Analytics
NCT01750827A Study to Assess the Effect of SB 659032 on Platelet FunctionAtherosclerosis
COMPLETED14 Analytics
PHASE1COMPLETED
SB-659032 Platelet Aggregation Study
AtherosclerosisUnlock trial analytics
PHASE1COMPLETED
A Study to Assess the Effect of SB 659032 on Platelet Function
AtherosclerosisUnlock trial analytics

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 to 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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Frequently asked questions about SB-659032

What is SB-659032 used for?

SB-659032 is an investigational small molecule being developed for atherosclerosis, a cardiovascular condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its effects on platelet function in the context of this disease.

Who makes SB-659032?

SB-659032 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting early-stage clinical trials to evaluate the drug's safety and effects in healthy volunteers.

What phase is SB-659032 in?

SB-659032 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is still investigational and has not received regulatory approval for any indication.

What clinical trials is SB-659032 in?

SB-659032 has been studied in two completed Phase 1 trials. NCT01745458, a platelet aggregation study with 26 male participants in Australia, and NCT01750827, a study on platelet function with 14 participants in the United States. Both trials enrolled healthy volunteers aged 18 years and older.

How does SB-659032 work?

SB-659032 is a small molecule that targets platelet function, as indicated by the clinical trials studying its effect on platelet aggregation and function. This mechanism is relevant to atherosclerosis, a condition where platelet activity contributes to disease progression.