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

Esperion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Mild Dyslipidemia

Treatments: Drug: ETC-1002 or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105598

ETC-1002-002

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Treatment:

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Cohort 2

Experimental group

Description:

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Treatment:

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Cohort 3

Experimental group

Description:

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Treatment:

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Cohort 4

Experimental group

Description:

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Treatment:

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Cohort 5

Experimental group

Description:

Free-living subjects (18 active/6 placebo) with mild dyslipidemia

Treatment:

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo

Drug: ETC-1002 or placebo