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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
single dose
GSK Investigational Site
Lenexa, Kansas, United States
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
Time frame: 24 hours
PK of SB-659032 and SB-664601
Cmax of SB-659032 and concentrations of SB-659032 at collection timepoints over
Time frame: 24 hours
Pharmacodynamics
Plasma Lp-PLA2 activity, expressed in terms of percent inhibition
Time frame: 24 hours
Safety/tolerability
Spontaneous AE reporting, 12-lead ECGs, vital signs, nursing/physician observation, and clinical laboratory tests
Time frame: 24 hours
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