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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Presidio Pharmaceuticals, Inc.

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)