A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
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- Safety/tolerability of single oral doses of darapladib [ Time Frame: 4, 24 and 96h post-dose ]
- Primary Pharmacokinetic parameters of single oral doses of darapladib [ Time Frame: pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose ]
Secondary Outcome Measures
-Secondary PK parameters -PK parameters of SB553253 -inhibition of Lp-PLA2 activity -description of plasma concentration-Lp-PLA2 activity inhibition relationship after single oral doses of darapladib. all measured same timepoints as primary PK [ Time Frame: Throughout the study ]
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Ages Eligible for Study:
20 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Japanese males, 20-64 years of age, inclusive
Body weight >50Kg
Body Mass Index (BMI): 18-28
Subjects must have lived outside of Japan no more than 10 years
Non-smoker or smokes fewer than 10 cigarettes/day
History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
History of sensitivity to heparin or heparin-induced thrombocytopenia
History of alcohol/drug abuse or dependence within 12 months of the study
Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C
History of cholecystectomy or biliary tract disease or history of liver disease
Participation in a clinical study within 30 days prior to first dose
Subject has been exposed to more than 4 chemical entities within 12 months
Positive urine drug and alcohol at screening
Subject has any medical history or clinically relevant abnormality that would make the subject ineligible for inclusion due to safety reasons.