Study of MB07811 in Subjects With Hypercholesterolemia

Exclusion Criteria

• •History of clinically significant cardiovascular disease
• •Uncontrolled hypertension
• •Significant sinus bradycardia defined as \<40 beats per minute (bpm);
• •Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome;
• •Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency \> 1 per minute, any alert criteria or any other condition that requires further evaluation;
• •History of clinical significant arrhythmia;
• •Resting 12-lead ECG showing QTc \>450 msec or \<360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality;
• •Any other cardiovascular event requiring hospitalization;
• •History or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; Exceptions: polycystic ovarian syndrome (PCOS) and impaired glucose tolerance (IGT) are allowed.
• •Liver disease, gallbladder disease, Gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (NASH), positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies; Exceptions: gallbladder disease treated with cholecystectomy
• •History of human immunodeficiency virus (HIV);
• •Subjects with a prior history of malignancy in past 5 years;Exceptions: Subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated;
• •History of myopathy, including any history of statin-induced myopathy;
• •History of intolerance to statins (e.g., myalgias, elevated liver tests);
• •History of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis;
• •Renal dysfunction;
• •Alcohol and/or drug abuse within 12 months prior to screening;