This study is being conducted to provide safety, tolerability, PK and PD data in repeat dosing that will allow further studies with darapladib in Japanese patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
GSK Investigational Site
Ibaraki, Japan
Safety/tolerability of repeat oral doses of darapladib
Primary Pharmacokinetic parameters of repeat oral doses of darapladib
-Secondary PK parameters
Tmax, and t1/2 of SB-480848 and AUC, Cmax, t1/2 and Tmax of the pharmacologically active metabolite SB-553253 (as data permit)
Plasma Lp-PLA2 activity, expressed in terms of percent inhibition relative to baseline
Estimation of PK/PD parameters and their associated variability, appropriate to the final models
-PK parameters of SB553253
-description of plasma concentration-Lp-PLA2 activity inhibition relationship after repeat oral doses of darapladib. all measured same timepoints as primary
-inhibition of Lp-PLA2 activity
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