An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks

Exclusion Criteria

• •Recent (i.e., \<6 months from Screening Visit) CV event defined as ST-elevation MI or non-ST-elevation MI, confirmed by cardiac enzyme elevation and ECG changes, coronary revascularization (PCI or CABG), stroke of any etiology, resuscitated sudden death, prior carotid surgery or stenting procedure
• •Evidence of clinical instability or abnormal clinical laboratory findings prior to randomization that, in the opinion of the Investigator, makes the subject unsuitable for the study.
• •Exposure to substantial radiation within the past 12 months
• •Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy), PCI or major non-cardiac surgery within the study period
• •Current inadequately controlled hypertension (blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic) on a stable dose of anti-hypertensive medication
• •Diabetics taking injectable insulin at screening
• •Serum triglycerides \>400 mg/dL, LDLc \>130 mg/dL
• •Recent (\<1 month) or ongoing acute infection.
• •History of chronic inflammatory disease
• •Recently received (\<1 month) or currently receiving oral or injectable corticosteroids, or regular use of nasal, inhaled or topical corticosteroids.
• •Subjects who will commence, or who are likely to commence regular treatment with oral, non-steroidal anti-inflammatory drugs (NSAIDs) from screening until study completion
• •Currently receiving oral or injectable potent CYP3A4 inhibitor(s)
• •History of chronic viral hepatitis or other chronic hepatic disorders; or ALT or AST \>1.5 x ULN, or alkaline phosphatase or total bilirubin \>1.5 x ULN of laboratory reference range at Screen
• •Renal impairment with serum creatinine \>2.0 mg/dl or history of kidney transplant or status post nephrectomy.
• •History of myopathy or inflammatory muscle disease, or elevated total CPK at screening
• •History of severe heart failure defined as NYHA class III or IV or those with known severe left ventricular dysfunction (ejection fraction\<30%) regardless of symptomatic status
• •History of adult asthma (or reactive airway disease) manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s)
• •History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions or severe allergic responses
• •History of malignancy within the past 2 years.
• •A history of glaucoma or any other findings in the baseline eye exam
• •Current life-threatening condition other than vascular disease that may prevent a subject from completing the study
• •QTc interval ≥450msec at screening or ≥480 msec for subjects with bundle branch block
• •History of drug abuse within the past 6 months
• •Previous exposure to rilapladib.
• •Contraindication to MRI scanning
• •Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication
• •Any other subject the Investigator deems unsuitable for the study