Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.