A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Esperion Therapeutics, Inc.
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements
- •Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL
- •Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only)
- •Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight >50 kg
Exclusion Criteria
- •Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- •Alanine aminotransferase (ALT) or aspartate amino transferase (AST) >1.2 x ULN; serum creatinine >ULN; hemoglobin <12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant
- •Use of tobacco or tobacco products
- •Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin >500 mg/day or fish oil which will not have been used for 3 months prior to randomization
- •Other exclusion criteria apply
Arms & Interventions
Cohort 1
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Intervention: ETC-1002 or placebo (Drug)
Cohort 2
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Intervention: ETC-1002 or placebo (Drug)
Cohort 3
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Intervention: ETC-1002 or placebo (Drug)
Cohort 4
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Intervention: ETC-1002 or placebo (Drug)
Cohort 5
Free-living subjects (18 active/6 placebo) with mild dyslipidemia
Intervention: ETC-1002 or placebo (Drug)
Outcomes
Primary Outcomes
Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values
Time Frame: 14 or 28 days
Secondary Outcomes
- Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints(14 or 28 days)