A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation

Exclusion Criteria

• •History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction \[ejection fraction less than 30%\] regardless of symptomatic status.
• •Suspected aortic dissection.
• •Severe aortic stenosis or other severe valvular disease.
• •Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.
• •Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic or acute inflammation (e.g. inflammatory bowel disease, osteomyelitis, pneumonia, etc.). Intermittent conditions treated with short-term oral antibiotics (e.g. typical URI) or conditions that are not currently exacerbated (e.g. gout with no current flair) may be included.
• •History of myopathy or rhabdomyolysis.
• •Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •Known to be Hepatitis B or Hepatitis C positive.
• •Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal and topical steroids are allowed. A single prophylactic dose of systemic steroid is allowed at time of PCI for subjects with contrast allergy.
• •Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g. daunorubicin, doxorubicin, topotecan, mitoxantrone).
• •Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary..
• •Known alcohol or drug abuse within the past 6 months.
• •Previous exposure to GW856553.
• •Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study.
• •Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication non-compliance).
• •Unwillingness or inability to follow the procedures outlined in the protocol.
• •Previous MI or coronary artery bypass graft (CABG) surgery.
• •History of kidney transplant or a history of contrast nephropathy.
• •Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but is not limited to: intracranial aneurysm clips or other metallic objects; history of intra-orbital metal fragments that have not been removed by an MD; pacemakers and non-MR compatible heart valves; inner ear implants; history of claustrophobia in MR.
• •Allergy to MRI contrast enhancement agent (gadolinium).
• •Estimated creatinine clearance by Cockcroft-Gault formula \< 30 mL/min.