Status:
COMPLETED
A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
Lead Sponsor:
Presidio Pharmaceuticals, Inc.
Conditions:
Chronic Genotype 1 Hepatitis C Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01247194
Start Date
October 1 2010
End Date
June 1 2011
Last Update
February 3 2012
Active Locations (11)
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1
Local Institution
Sacramento, California, United States, 95817
2
Local institution
San Francisco, California, United States, 94115
3
Local institution
Aarhus, Denmark
4
Local institution
Copenhagen, Denmark