This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
137
Novartis Investigative Site
Miramar, Florida, United States
Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia
Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
Time frame: Up to 21 days
TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia.
Time frame: 25 timepoints over 17 days
Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.
Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.
Time frame: 10 days
Effect of food on TAP311 blood concentration in healthy subjects.
TAP311 blood concentration when the drug is administered with and without food.
Time frame: 3 days
Effects of TAP311 on total cholesterol in patients with dyslipidemia
Total cholesterol blood concentration before and after TAP311 treatment.
Time frame: 8 timepoints over 15 days
Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia
LDL-C blood concentration before and after TAP311 treatment.
Time frame: 8 timepoints over 15 days
Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.
HDL-C blood concentration before and after TAP311 treatment.
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Time frame: 8 timepoints over 15 days
Effects of TAP311 on triglycerides in patients with Dyslipidemia
Triglycerides concentration in blood before and after TAP311 treatment.
Time frame: 8 timepoints over 15 days