A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects

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.

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 exclusion criteria apply