Dyslipidaemia
Conditions
Keywords
safety, tolerability, pharmacokinetics
Brief summary
The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.
Interventions
DRUGTAP311 capsules
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | 14 days after treatment | Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Day 1 | The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) |
| Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss) | Day 1 and Day 14 | Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure |
| Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss) | Day 1 and Day 14 profile | The time to reach the maximum concentration after drug administration at steady state(Tmax, ss) |
| Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data | Day 14 | The Racc ratio from the plasma concentration-time data |
| Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data | Day 14 | The AUCtau, from the plasma concentration-time data |
Countries
Jordan, Taiwan, United States
Outcome results
None listed