Safety Evaluation of Escalating Doses
Conditions
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.
Interventions
DRUGETC-1002
escalating doses
Sponsors
Esperion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Major 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures. | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood. | 14 days |
Countries
United States
Outcome results
None listed