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Completed

NCT Number: NCT01105598

A Multiple Ascending Dose Study 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.

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Key information

Conditions

Mild Dyslipidemia

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETC-1002 or placebo

Drug

ETC-1002 (ascending dose), daily for 14 days

Primary outcomes

  1. Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values

    Time frame: 14 or 28 days

Secondary outcomes

  1. Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2010
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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