Status:
COMPLETED
A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects
Lead Sponsor:
Esperion Therapeutics, Inc.
Conditions:
Safety Evaluation of Escalating Doses
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
October 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01485146
Start Date
October 25 2011
End Date
January 25 2012
Last Update
March 28 2019
Active Locations (1)
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1
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States, 49007