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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Genotype 1 Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: PPI-461
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort A<br>PPI-461 50 mg or placebo | Drug: PPI-461<br>* capsule, oral, once daily for 3 days<br>Drug: Placebo<br>* capsules, oral, once daily for 3 days<br>|
| Active Comparator: Cohort B<br>PPI-461 100 mg or placebo | Drug: PPI-461<br>* capsule, oral, once daily for 3 days<br>Drug: Placebo<br>* capsules, oral, once daily for 3 days<br>|
| Active Comparator: Cohort C<br>PPI-461 200 mg or placebo | Drug: PPI-461<br>* capsule, oral, once daily for 3 days<br>Drug: Placebo<br>* capsules, oral, once daily for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, as measured by clinical adverse events and laboratory assessments |  | up to Study Day 16 (14 days after the last PPI-461 dose) | 
| Antiviral effects of PPI-461, as measured by HCV RNA levels |  | Up to Study Day 16 (14 days after the last PPI-461 dose) | 
| PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations |  | Up to Study Day 10 (8 days after the last PPI-461 dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C, NS5A, HCV RNA