A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
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A 28-day, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 (7.5 mg) in Subjects With Coronary Heart Disease (CHD) Undergoing Elective Percutaneous Coronary Interventions (PCI)
Study Start Date
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Females must be of non-child-bearing potential.
Female subjects must have a negative pregnancy test.
Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography.
Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL <130 mg/dL (3.4 mmol/L) at Screening visit.
Must be capable of providing informed consent.
Have an hsCRP concentration of >2 mg/L, but < 10 mg/L at screening.
Women who are pregnant or breast feeding.
Planned PCI with multi-vessel stenting.
Planned PCI with additional revascularization procedures staged at different days during the study period.
Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc).
Planned PCI of any bypass graft.
History of CABG surgery.
Planned cardiac or major non-cardiac surgery within the study period.
Disabling stroke in the past 6 months.
History of chronic viral hepatitis or other chronic hepatic disorders.
History of Gilbert's syndrome or elevated bilirubin concentrations at screening.
History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months.
Renal impairment with serum creatinine >2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy.
Current inadequately controlled hypertension (blood pressure >160 mmHg systolic and/or >100 mmHg diastolic) on a stable dose of antihypertensive medication.
Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screening.
History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF<30%) regardless of symptomatic status.
History of malignancy within the past 5 years, other than non-melanoma skin cancer.
Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.