phase i study of sb-480848(darapladib) -repeat dose study in healthy japanese male subjects-

Conditions: Atherosclerosis

Summary: 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


Eligibility criteria:
inclusion criteria: * healthy japanese adult males between 20 and 64 yeas of age, inclusive. * healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ecg, immunology tests and urinary drug screen test. * bodyweight \>50 kg and body mass index (bmi) between 18.5 and 25.0 at screening. * subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * baseline qtc interval \<450 msec. * non-smoker or ex-smoker having ceased smoking for at least 6 months. * clinical laboratory examination (ast, alt, alp and ggt) at screening are within the normal range. * the subject is able to attend all visits and complete the study. exclusion criteria: * any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ecg recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern. * history of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 ml) of wine or 350 ml of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits) within 6 months of screening. * positive for urine drug at screening. * positive for syphilis, hiv antibody, hepatitis b surface antigen, hepatitis c antibody or htlv-1 antibody at screening. * use of prescription or no-prescription drugs, including vitamins, herbal and dietary supplements (including st john's wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. * consumption of grapefruit juice or food within 7 days prior to the first dose of study medication. * a history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology. * donation of blood in excess of 400ml within 4 months or 200ml within 1 months prior to at screening. * history of drug abuse, or current conditions of drug abuse or alcoholism. * participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication. * participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device. * history of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses. * the subject has an allergy for any drug or idiosyncrasy. this excludes a pollen allergy without current symptoms. * history of sensitivity to heparin or heparin-induced thrombocytopenia.

Keywords: darapladib, sb480848, japanese healthy volunteers