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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 55
Updated:3/30/2019
Start Date:April 20, 2010
End Date:October 2, 2010

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

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.


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
We found this trial at
1
site
Kalamazoo, Michigan 49007
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mi
from
Kalamazoo, MI
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