Trial | NCT01105598  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bempedoic acid ...

  • Study Participants

    53
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.
Study Started
Apr 20
2010
Primary Completion
Oct 02
2010
Study Completion
Oct 02
2010
Last Update
Mar 28
2019

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

Cohort 1 Experimental

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

Cohort 2 Experimental

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

Cohort 3 Experimental

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

Cohort 4 Experimental

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

Cohort 5 Experimental

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

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
No Results Posted