Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients
