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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
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| Cohort 2 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
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| Cohort 3 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
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| Cohort 4 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
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| Cohort 5 | Experimental | Free-living subjects (18 active/6 placebo) with mild dyslipidemia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETC-1002 or placebo | Drug | ETC-1002 (ascending dose), daily for 14 days |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim C Khalifa, MD | Esperion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic, Inc. | Kalamazoo | Michigan | 49007 | United States |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
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| ETC-1002 or placebo | Drug | ETC-1002 (optimized dose), daily for 28 days |
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| ETC-1002 or placebo | Drug | ETC-1002 (20 mg), daily for 14 days |
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