Trial | NCT01247194  Report issue

Title

A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ppi-461 ...

  • Study Participants

    24
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.
Study Started
Oct 31
2010
Primary Completion
May 31
2011
Study Completion
Jun 30
2011
Last Update
Feb 03
2012
Estimate

Drug PPI-461

capsule, oral, once daily for 3 days

Drug Placebo

capsules, oral, once daily for 3 days

Cohort A Active Comparator

PPI-461 50 mg or placebo

Cohort B Active Comparator

PPI-461 100 mg or placebo

Cohort C Active Comparator

PPI-461 200 mg or placebo

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)
No Results Posted