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

Phase 1

Completed

• Conditions: Mild Dyslipidemia
• Interventions: Drug: ETC-1002 or placebo

• Registration Number: NCT01105598
• Lead Sponsor: Esperion Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Study Start: 2010-04-20
• Primary Completion: 2010-10-02
• Study Completion: 2010-10-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4	ETC-1002 or placebo	Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Cohort 5	ETC-1002 or placebo	Free-living subjects (18 active/6 placebo) with mild dyslipidemia
Cohort 1	ETC-1002 or placebo	Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Cohort 3	ETC-1002 or placebo	Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Cohort 2	ETC-1002 or placebo	Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints	14 or 28 days	Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)

Trial Locations

Locations (1)

Jasper Clinic, Inc.; 🇺🇸 Kalamazoo, Michigan, United States