Overview

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)