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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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014