A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
Completed · Phase 1 · Has a placebo group
Conditions studied: Mild Dyslipidemia
In brief
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.
Key facts
- Study ID
- NCT01105598
- Run by
- Esperion Therapeutics, Inc.
- People needed
- 53
- Starts
- 2010-04-20
- Expected to finish
- 2010-10-02
- Last updated by the study team
- 2019-03-28
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
Full record on ClinicalTrials.gov
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