Clinical trial NCT01247194: A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
Official title: A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Genotype 1 Hepatitis C Virus Infection
Keywords: hepatitis C
NS5A
HCV RNA
Lead sponsor: Presidio Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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)

Primary outcomes:
measure: Safety and tolerability, as measured by clinical adverse events and laboratory assessments
timeFrame: up to Study Day 16 (14 days after the last PPI-461 dose)
measure: Antiviral effects of PPI-461, as measured by HCV RNA levels
timeFrame: Up to Study Day 16 (14 days after the last PPI-461 dose)
measure: PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations
timeFrame: Up to Study Day 10 (8 days after the last PPI-461 dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local institution
state: California
city: Aarhus
country: Denmark
facility: Local institution
city: Copenhagen
country: Denmark
facility: Local institution
city: Herlev
country: Denmark
facility: Local institution
city: Hvidovre
country: Denmark
facility: Local institution
city: Kolding
country: Denmark
facility: Local institution
city: Odense
country: Denmark
facility: Local institution
city: London
country: United Kingdom
facility: Local institution
city: London
country: United Kingdom
facility: Local institution
city: London
country: United Kingdom
facility: Local institution
Study officials:
affiliation: Presidio Pharmaceuticals
name: Nathaniel Brown, M.D.
role: STUDY_DIRECTOR
References: