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

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

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 Overview

• Status: Completed
• Conditions: Mild Dyslipidemia
• Intervention / Treatment: Drug: ETC-1002 or placebo; Drug: ETC-1002 or placebo; Drug: ETC-1002 or placebo

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Jasper Clinic, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Esperion Therapeutics, Inc.
• Investigators: Study Director: Jim C Khalifa, MD, Esperion Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2010
• Primary Completion (ACTUAL): October 2, 2010
• Study Completion (ACTUAL): October 2, 2010

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (ESTIMATE): April 16, 2010

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
• Other Study ID Numbers: ETC-1002-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No