Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

Novartis

Status and phase

Completed

Phase 1

Conditions

Dyslipidaemia

Treatments

Drug: TAP311 capsules

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

CTAP311X2201

2012-000857-29

Details and patient eligibility

About

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

Enrollment

279 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.