A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1

Inclusion Criteria

• •Eligibility Criteria:
• •Male or female, between 18 and 65 years of age (female patients must be surgically sterile or 2 years post-menopausal and are required to take a pregnancy test)
• •Body Mass Index (BMI) 18 - 32 kg/m2
• •Chronically infected with hepatitis C genotype-1 virus
• •Serum HCV RNA \> 5 log10 IU/mL
• •No previous treatment with interferon, peginterferon, ribavirin or any investigational HCV antiviral agents
• •No history of signs or symptoms of decompensated liver disease
• •No known history of cirrhosis
• •No co-infection with HBV, HIV-1, HIV-2
• •No history of any medical condition that may interfere with absorption, distribution or elimination of study drug or with the clinical and laboratory assessments in this study
• •No history of alcohol abuse, or illicit drug use within 2 years prior to Screen, or enrollment in a methadone maintenance program (unless he/she has been enrolled in the methadone program for at least 3 months with good compliance, stable psychosocial circumstances, and no known current risks for recidivism)