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

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:

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)


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 (Adult)
Sexes Eligible for Study:	All
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


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

Additional relevant MeSH terms:


Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on July 14, 2017