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

This study has been completed.
Sponsor:
Information provided by:
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01105598
First received: April 15, 2010
Last updated: November 16, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Mild Dyslipidemia
 Drug: ETC-1002 or placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values [ Time Frame: 14 or 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints [ Time Frame: 14 or 28 days ] [ Designated as safety issue: No ]
    Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)


Enrollment: 53
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105598

Locations
United States, Michigan
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Esperion Therapeutics
  More Information

No publications provided

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01105598     History of Changes
Other Study ID Numbers: ETC-1002-002
Study First Received: April 15, 2010
Last Updated: November 16, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013