A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia

Study Overview
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Brief Summary
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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.

Official Title
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A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia

Conditions
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Mild Dyslipidemia

Intervention / Treatment
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* Drug: ETC-1002 or placebo
* Drug: ETC-1002 or placebo
* Drug: ETC-1002 or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit | Drug: ETC-1002 or placebo<br>* ETC-1002 (20 mg), daily for 14 days<br>|
| Experimental: Cohort 2<br>Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit | Drug: ETC-1002 or placebo<br>* ETC-1002 (ascending dose), daily for 14 days<br>|
| Experimental: Cohort 3<br>Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit | Drug: ETC-1002 or placebo<br>* ETC-1002 (ascending dose), daily for 14 days<br>|
| Experimental: Cohort 4<br>Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit | Drug: ETC-1002 or placebo<br>* ETC-1002 (ascending dose), daily for 14 days<br>|
| Experimental: Cohort 5<br>Free-living subjects (18 active/6 placebo) with mild dyslipidemia | Drug: ETC-1002 or placebo<br>* ETC-1002 (optimized dose), daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values |  | 14 or 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 14 or 28 days |