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

Primary Purpose

Mild Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ETC-1002 or placebo
ETC-1002 or placebo
ETC-1002 or placebo
Sponsored by
Esperion Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Dyslipidemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jasper Clinic, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Free-living subjects (18 active/6 placebo) with mild dyslipidemia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)

Full Information

First Posted
April 15, 2010
Last Updated
March 26, 2019
Sponsor
Esperion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01105598
Brief Title
A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
Official Title
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2010 (Actual)
Primary Completion Date
October 2, 2010 (Actual)
Study Completion Date
October 2, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esperion Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Free-living subjects (18 active/6 placebo) with mild dyslipidemia
Intervention Type
Drug
Intervention Name(s)
ETC-1002 or placebo
Intervention Description
ETC-1002 (ascending dose), daily for 14 days
Intervention Type
Drug
Intervention Name(s)
ETC-1002 or placebo
Intervention Description
ETC-1002 (optimized dose), daily for 28 days
Intervention Type
Drug
Intervention Name(s)
ETC-1002 or placebo
Intervention Description
ETC-1002 (20 mg), daily for 14 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
Description
Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)
Time Frame
14 or 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim C Khalifa, MD
Organizational Affiliation
Esperion Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Jasper Clinic, Inc.
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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