A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
The purpose of the study is to assess the safety, tolerability, antiviral effects, and
 pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.
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)