This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
ETC-1002 (ascending dose), daily for 14 days
ETC-1002 (optimized dose), daily for 28 days
ETC-1002 (20 mg), daily for 14 days
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values
Time frame: 14 or 28 days
Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)
Time frame: 14 or 28 days
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