A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects
- Registration Number
- NCT01485146
- Lead Sponsor
- Esperion Therapeutics, Inc.
- Brief Summary
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
- Body Mass Index of 18-32 kg/m2 inclusive with body weight >50 kg
Major
Exclusion Criteria
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2 x Upper Limit of Normal(ULN), serum creatinine >ULN, Hemoglobin <12.0 g/dL
- Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
- Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization
- Other exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 ETC-1002 8 Healthy Subjects in Phase I Unit Cohort 3 ETC-1002 8 Healthy Subjects in Phase I Unit Cohort 2 ETC-1002 8 Healthy Subjects in Phase I Unit
- Primary Outcome Measures
Name Time Method Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures. 14 days
- Secondary Outcome Measures
Name Time Method Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood. 14 days
Trial Locations
- Locations (1)
Jasper Clinic, Inc.
🇺🇸Kalamazoo, Michigan, United States