Safety, PK and Efficacy of 15 Days of SCY-635 Treatment in Hepatitis C Patients

Exclusion Criteria

• •The subject has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Principal Investigator, may jeopardize the safety of the subject or may impact the validity of the study results.
• •The subject is infected with any HCV genotype other than genotype 1.
• •The subject has documented positive antibody tests for Human Immunodeficiency Virus Types 1 or 2 (p24 antibody specific for HIV-1 or HIV-2) or Hepatitis B virus (HBV) surface antigen (HbSAg) or at Screening exhibits serologic evidence of infection with either HIV-1, HIV-2 or HBV.
• •The subject has donated blood within 30 days prior to dosing or donated plasma within 14 days prior to dosing.
• •The subject has used any investigational agent within three months prior to dosing.
• •The subject has received any FDA-approved anti-HCV therapy (including ribavirin or any product that contains interferon) within three months prior to dosing.
• •The subject exhibits evidence of decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less than 3.0 g/dL, prothrombin time greater than 2 seconds prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
• •The subject is an organ transplant recipient.
• •The subject exhibits ALT values greater than or equal to 2.5 times the upper limit of normal.
• •The subject exhibits evidence of hepatocellular carcinoma either by exhibiting a serum alpha-fetoprotein concentration which exceeds 50 mg/L or by exhibiting a mass suggestive of liver cancer by ultrasound or other imaging technology.
• •The subject exhibits evidence of ongoing alcohol or substance abuse.