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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01247194

Enrollment

Registered

2010-11-24

Start date

2010-10-31

Completion date

2011-06-30

Last updated

2012-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Genotype 1 Hepatitis C Virus Infection

Keywords

hepatitis C, NS5A, HCV RNA

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.

Interventions

DRUGPPI-461

capsule, oral, once daily for 3 days

DRUGPlacebo

capsules, oral, once daily for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	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)

Countries

Denmark, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026