The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
279
Novartis Investigative Site
Miramar, Florida, United States
Novartis Investigative Site
Amman, Jordan
Novartis Investigative Site
Taichung, Taiwan, Taiwan
Number of patients with adverse events
Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.
Time frame: 14 days after treatment
Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)
Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure
Time frame: Day 1 and Day 14
Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
Time frame: Day 1 and Day 14 profile
Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Day 1
Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data
The Racc ratio from the plasma concentration-time data
Time frame: Day 14
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data
The AUCtau, from the plasma concentration-time data
Time frame: Day 14
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