EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients

Inclusion Criteria for Healthy Volunteers (SAD and MAD Phases): * Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * Female subjects must be of non-childbearing potential. * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug. * Body mass index of 18 to 30 kg/m2 with a minimum body weight of 50 kg. * An informed consent document signed and dated by the subject. Exclusion Criteria for Healthy Volunteers (SAD and MAD Phases): * Clinically relevant evidence or history of illness or disease * Pregnant or nursing females. * History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * A positive urine drug screen at screening or Day -1. * Any condition possibly affecting drug absorption (e.g., gastrectomy). * History of regular alcohol consumption * Participation in a clinical trial within 30 days prior to study drug administration. * Use of prescription drugs, non-prescription drugs, dietary supplements, herbal supplements, hormonal therapy/replacement or CYP3A4 substrates, inducers and inhibitors within 14 days prior to the first dose of study medication Inclusion Criteria for HCV-Infected Subjects (POC Phase): * Males and females aged 18 years and less than 70 years. * Female subjects must be of non-childbearing potential. * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug. * Body mass index of 18 to 36 kg/m2 with a minimum body weight of 50 kg. * Treatment naïve subjects with chronic HCV infection, * HCV GT1 (including 1a, 1b, or mixed subtypes of GT1) or GT3. * HCV RNA ≥100,000 IU/mL at screening. * An informed consent document signed and dated by the subject. Exclusion Criteria for HCV-Infected Subjects (POC Phase): * Women of childbearing potential (WOCBP). * Pregnant or nursing females. * History of febrile illness within 7 days prior to the first dose of study drug. * A positive urine drug screen at screening unless on an approved prescription. * History of participation in a clinical trial with a polymerase inhibitor or previous treatment with a polymerase inhibitor, where at least one dose of the polymerase inhibitor was consumed. Subjects who were dosed with placebo on a clinical trial may be enrolled in this study. * Clinically significant electrocardiogram abnormalities or QTcF greater than 450 msec for males and 470 msec for females at either screening or baseline, or any prior history of QT abnormality. * Co-infection with HIV-1, HIV-2 or HBV. * Have clinically significant laboratory abnormalities at screening: * Absolute neutrophil count (ANC) \< 1500/mm2 (1.5 x 109L) * Platelets \<90,000/mm2 (90 x 109L) * Hemoglobin \< 13g/dL for males and \< 12g/dL for females * Serum creatinine \>1.5 x upper limit of normal (ULN) or creatinine clearance \< 50 mL/min; estimated by the cockcroft -Gault formula \[(140-age) x weight (kg)/72 x serum creatinine (mg/dL), if female multiply by 0.85\] * Total bilirubin greater than the ULN * Serum alanine transaminase (ALT) \> 5 x ULN * Serum aspartate aminotransferase (AST) \> 5 x ULN * Alkaline phosphatase \> 1.25 x ULN * Pancreatic Amylase \> 1.1 x ULN * Alpha fetoprotein (AFP) \> 50 ng/mL unless a liver imaging study (CT, MRI) shows no clinically significant lesions within 6 months prior to the first dose of study drug. * Patients with evidence of cirrhosis; cirrhosis is defined as any one of the following: a) any biopsy showing cirrhosis (Knodell score \<3, Metavir score \<3, Ishak score \<4); b) Fibroscan evaluation within 6 months prior to screening with a liver stiffness score of \>\<12.5 kPa. * Other significant, unstable or uncontrolled medical history, such as neurological, endocrine, malignancy, renal, psychiatric, respiratory, cardiac, gastrointestinal, allergic, immunological, etc. disease. * Use of concomitant medications, including vitamins or herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication