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This will be an open-label, single dose, single period study. Approximately 14 subjects will receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast. This study will evaluate whether SB-659032 has an effect on platelet function as determined by platelet aggregation tests using the agonists ADP and collagen. Blood samples for PK analysis and measurement of Lp-PLA2 activity will also be collected
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB-659032 | Experimental | Single dose open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB659032 | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet aggregation | Percent maximum platelet aggregation following ADP- and collagen-induced aggregation a 24-hour post-dose period. Other pharmacokinetic endpoints of interest are Tmax of SB-659032 and its pharmacologically active metabolite, SB-664601, as well as Cmax of SB-664601 and concentrations of SB-664601 over a 24-hour post-dose | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PK of SB-659032 and SB-664601 | Cmax of SB-659032 and concentrations of SB-659032 at collection timepoints over | 24 hours |
| Pharmacodynamics | Plasma Lp-PLA2 activity, expressed in terms of percent inhibition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000592856 | rilapladib |
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| 24 hours |
| Safety/tolerability | Spontaneous AE reporting, 12-lead ECGs, vital signs, nursing/physician observation, and clinical laboratory tests | 24 hours |