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

Mild Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105598
• Other study ID #: ETC-1002-002
• Status: Completed
• Phase: Phase 1
• Start date: April 20, 2010
• Est. completion date: October 2, 2010

Study information

• Verified date: March 2019
• Source: Esperion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2, 2010
• Est. primary completion date: October 2, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Mild Dyslipidemia

Intervention

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

Locations

Country	Name	City	State
United States	Jasper Clinic, Inc.	Kalamazoo	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Esperion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values		14 or 28 days
Secondary	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)	14 or 28 days