Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Percentage change of LDL plasma cholesterol
Time frame: baseline, 2 weeks
Percentage change of total plasma cholesterol
Time frame: baseline, 2 weeks
Percentage change in lipid profile
Time frame: baseline, 1 week
Number of patients with adverse events
Time frame: Up to day 42
Number of patients with clinical significant findings in eye lens opacification
Time frame: Up to day 42
Number of patients with clinical significant findings in laboratory parameters
Time frame: Up to day 28
Number of patients with clinical significant findings in electrocardiogram (ECG)
Time frame: Up to day 28
Number of patients with clinical significant findings in physical examination
Time frame: Up to day 28
Number of patients with clinical significant findings in vital signs
Time frame: Up to day 15
Investigator assessed tolerability on a 4 point scale
Time frame: day 42
Amount of drug excreted in urine
Time frame: Up to day 15
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Drug plasma concentration
Time frame: Up to day 28
Monoepoxysqualene (MES) plasma concentration
Time frame: Up to day 28