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 |
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.
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
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