The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
Gemcabene 50 mg once daily (QD)
Gemcabene 150 mg once daily (QD)
Gemcabene 450 mg once daily (QD)
Pharmacokinetics
Cmax
Time frame: 29 days
Pharmacokinetcis
Area Under the Curve (AUC)
Time frame: 29 days
Plasma lipid levels - percent change from baseline at Day 29
percent change from baseline for LDL-C, apolipoprotein B (apoB), total cholesterol (TC), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
Time frame: 29 days
Adverse Events
Time frame: 29 days
ECG
Clinically Significant Changes
Time frame: 29 days
Clinical Laboratory - hematology, chemistry
Clinical Laboratory Abnormalities
Time frame: 29 days
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Gemcabene 750/600 mg once daily (QD)
Gemcabene 900 mg once daily (QD)
Placebo once daily (QD)