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A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects

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. Identifier: NCT01485146
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : March 28, 2019
Information provided by (Responsible Party):
Esperion Therapeutics, Inc.

Brief Summary:
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.

Condition or disease Intervention/treatment Phase
Safety Evaluation of Escalating Doses Drug: ETC-1002 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects
Actual Study Start Date : October 25, 2011
Actual Primary Completion Date : January 25, 2012
Actual Study Completion Date : January 25, 2012

Arm Intervention/treatment
Experimental: Cohort 1
8 Healthy Subjects in Phase I Unit
Drug: ETC-1002
escalating doses

Experimental: Cohort 2
8 Healthy Subjects in Phase I Unit
Drug: ETC-1002
escalating doses

Experimental: Cohort 3
8 Healthy Subjects in Phase I Unit
Drug: ETC-1002
escalating doses

Primary Outcome Measures :
  1. Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood. [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Major Inclusion Criteria:

  • Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
  • Body Mass Index of 18-32 kg/m2 inclusive with body weight >50 kg

Major Exclusion Criteria:

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2 x Upper Limit of Normal(ULN), serum creatinine >ULN, Hemoglobin <12.0 g/dL
  • Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
  • History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
  • Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days 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 identifier (NCT number): NCT01485146

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United States, Michigan
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Esperion Therapeutics, Inc.
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Study Director: Narendra Lalwani, PhD Esperion Therapeutics, Inc.
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Responsible Party: Esperion Therapeutics, Inc. Identifier: NCT01485146    
Other Study ID Numbers: ETC-1002-004
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs