Study of SCY-635, Pegasys and Copegus in Hepatitis C

Exclusion Criteria

• •History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
• •Females who are pregnant or breastfeeding
• •Males with partners who are pregnant or are planning to become pregnant
• •HCV genotype other than genotype 1 and an IL28B genotype of C/C
• •Seropositive for HIV-1 or HIV-2 or hepatitis B virus (HBV) surface antigen (HBsAg)
• •Use of any investigational agent within 3 months prior to dosing
• •Received any prior FDA-approved or investigational drug or drug regimen for the treatment of hepatitis C
• •Evidence of cirrhosis on a previous liver biopsy
• •Evidence of decompensated liver disease
• •Recipient of an organ transplant
• •Evidence of hepatocellular carcinoma
• •Evidence of ongoing alcohol or substance abuse
• •Poorly-controlled diabetes mellitus
• •Congestive heart failure or unstable cardiopulmonary condition, renal disease, or hemoglobinopathy (sickle cell anemia or thalassemia
• •History of seizure disorder
• •History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, related hospitalizations, bipolar disorder, or psychosis requiring medication
• •Concurrent medical condition or laboratory abnormality that would constitute a contra-indication for interferon use
• •History of unstable thyroid disease that would preclude administration of interferon-based therapy
• •Medical condition that requires use of systemic corticosteroids
• •Received warfarin or other anticoagulants during the 21 days immediately prior to Screening, or is expected to require warfarin or other anticoagulants during the study.
• •One or more additional known primary or secondary causes of liver disease, other than hepatitis C
• •Any other concurrent medical condition likely to preclude compliance with the schedule of evaluations, or likely to confound the efficacy or safety observations
• •12-lead ECG showing the following:
• •* Corrected QTc interval ≥ 450 msec (Bazett's correction);
• •* QRS \> 120 msec;
• •* Clinically significant abnormalities;
• •Severe retinopathy or other significant ophthalmological disorder
• •Use of any herbal supplements within 28 days prior to dosing.
• •The use of CYP3A inducers or inhibitors for at least 2 weeks prior to initiation of treatment through Week 6