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

Tracking Information

First Received Date ^ICMJE

April 15, 2010

Last Updated Date

November 16, 2010

Start Date ^ICMJE

April 2010

Primary Completion Date

October 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values [ Time Frame: 14 or 28 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01105598 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints (including total cholesterol, LDL-C, TG, HDL-C and FFA) [ Time Frame: 14 or 28 days ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Mild Dyslipidemia

Intervention ^ICMJE

Drug: ETC-1002 or placebo
ETC-1002 (ascending dose), daily for 14 days
Drug: ETC-1002 or placebo
ETC-1002 (optimized dose), daily for 28 days
Drug: ETC-1002 or placebo
ETC-1002 (20 mg), daily for 14 days

Study Arms

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

Intervention: Drug: ETC-1002 or placebo
Experimental: Cohort 2
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Intervention: Drug: ETC-1002 or placebo
Experimental: Cohort 3
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Intervention: Drug: ETC-1002 or placebo
Experimental: Cohort 4
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit

Intervention: Drug: ETC-1002 or placebo
Experimental: Cohort 5
Free-living subjects (18 active/6 placebo) with mild dyslipidemia

Intervention: Drug: ETC-1002 or placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01105598

Other Study ID Numbers ^ICMJE

ETC-1002-002

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Esperion Therapeutics

Study Sponsor ^ICMJE

Esperion Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Esperion Therapeutics

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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