Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

Inclusion criteria

• Male and female patients 18 to 80 years (inclusive) of age.
• Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
• Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.

Exclusion criteria

• Use of other investigational drugs at the time of enrollment
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
• Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
• Pregnant or nursing (lactating) women
• Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
• Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).
• Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception
• Significant illness within two (2) weeks prior to initial dosing
• History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.