SB-480848 In Subjects With Coronary Heart Disease
Atherosclerosis
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring CHD, Lp-PLA2, SB-480848
Eligibility Criteria
Inclusion criteria: Female subjects must be of non-childbearing potential. Stable CHD or CHD-risk equivalent. Must have been on a stable dose of a statin for =4 weeks with LDL <130 mg/dL (3.4 mmol/L) or off statin therapy for =4 weeks with LDL <160 mg/dL (4.1 mmol/L). On a stable dose of at least one oral antiplatelet agent (e.g., aspirin, clopidogrel, or ticlopidine). Exclusion criteria: Recent cardiovascular event and / or vascular procedure. History of difficult to manage dyslipidemia. Planned cardiac surgery or PCI (percutaneous coronary intervention) or planned major non-cardiac surgery. Inadequately controlled hypertension. Poorly controlled diabetes mellitus. Serum triglycerides >400 mg/dL (4.52 mmol/L). Recent or ongoing acute infection. History of chronic inflammatory disease. Receiving topical, oral, inhaled or injectable corticosteroids. History of chronic viral hepatitis, or other chronic hepatic disorders. History of kidney transplant. History of myopathy or inflammatory muscle disease, or elevated total serum CK (3 x ULN). Severe heart failure (NYHA class III or IV), or severe left ventricular dysfunction (ejection fraction <30%). Asthma manifested by bronchospasm in the past 6 months, or currently taking inhaled bronchodilator on regular basis. History of anaphylaxis, anaphylactoid reactions or severe allergic responses within the past 6 months. Malignancy within the past 2 years, other than non-melanoma skin cancer. Current life-threatening condition other than vascular disease that may prevent a subject from completing the study. QTc interval >440 msec (males) or >450 msec (females). Alcohol or drug abuse within the past 6 months. Previous exposure to SB-480848. Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication (blinded atorvastatin).
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm 1
Arm 2
SB-480848
placebo