GSK Investigational Site
Lenexa, Kansas, 66219, United States
NCT Number: NCT01750827
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Lenexa, Kansas, 66219, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single dose
Time frame: 24 hours
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
Cmax of SB-659032 and concentrations of SB-659032 at collection timepoints over
Time frame: 24 hours
Plasma Lp-PLA2 activity, expressed in terms of percent inhibition
Time frame: 24 hours
Spontaneous AE reporting, 12-lead ECGs, vital signs, nursing/physician observation, and clinical laboratory tests
GlaxoSmithKline
Industry
A Single Dose Study to Assess the Effect of Non-Bioenhanced, Non-Enteric Coated, Freebase SB-659032 on Platelet Function in Healthy Adult Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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