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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01105598
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mild Dyslipidemia Drug: ETC-1002 or placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia
Actual Study Start Date : April 20, 2010
Actual Primary Completion Date : October 2, 2010
Actual Study Completion Date : October 2, 2010

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 (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

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

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

Experimental: Cohort 5
Free-living subjects (18 active/6 placebo) with mild dyslipidemia
Drug: ETC-1002 or placebo
ETC-1002 (optimized dose), daily for 28 days




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105598


Locations
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United States, Michigan
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Esperion Therapeutics, Inc.
Investigators
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Study Director: Jim C Khalifa, MD Esperion Therapeutics, Inc.
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Responsible Party: Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01105598    
Other Study ID Numbers: ETC-1002-002
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs