A Phase 1 interventional study of SB659032 in Atherosclerosis, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-17.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 14 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Single dose open label
Drug: SB659032
single dose
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
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline