Atherosclerosis Clinical Trial
Official title:
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of 160 mg Enteric-coated Micronised Free Base Darapladib in Healthy Chinese Subjects.
This study is to evaluate pharmacokinetics (PK), pharmacodynamics (PD) and safety of 160 mg enteric-coated micronised free base darapladib in healthy Chinese subjects.
SB-480848 (darapladib) is a novel selective and orally active inhibitor of
lipoprotein-associated phospholipase A2 (Lp-PLA2) being developed by GlaxoSmithKline (GSK)
for the treatment of atherosclerosis.
This will be an open label study where each Subject will participate in 2 study sessions, a
single dose session and a repeat dose session. All Subjects will receive 160 mg of enteric
coated micronised free-base darapladib as a single dose and as repeated daily doses for 28
days.
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD)
and safety of single and repeat oral dose of darapladib in healthy Chinese Subjects. The
primary endpoints for safety are: clinical safety data from spontaneous adverse event
reporting, 12-lead electrocardiogram recording, vital sign measurement, nursing/physician
observation and clinical laboratory tests. The primary PK parameters of interest are area
under plasma concentration time curve (AUC) and maximum plasma concentration (Cmax) of
darapladib, while the secondary PK parameters of interest are: time of occurrence of Cmax
(Tmax) and apparent terminal phase half-life (t1/2) of darapladib as well as AUC, Cmax, Tmax
and t1/2 of the metabolite, SB-553253. Finally, the PD endpoint of interest is plasma Lp
PLA2 activity, as expressed in terms of percent inhibition relative to baseline.
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