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Completed

NCT Number: NCT01247194

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

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.

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Key information

Conditions

Chronic Genotype 1 Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local institution, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PPI-461

Drug

capsule, oral, once daily for 3 days

Placebo

Drug

capsules, oral, once daily for 3 days

Primary outcomes

  1. Safety and tolerability, as measured by clinical adverse events and laboratory assessments

    Time frame: up to Study Day 16 (14 days after the last PPI-461 dose)

  2. Antiviral effects of PPI-461, as measured by HCV RNA levels

    Time frame: Up to Study Day 16 (14 days after the last PPI-461 dose)

  3. PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations

    Time frame: Up to Study Day 10 (8 days after the last PPI-461 dose)

Sponsors and collaborators

Lead sponsor

Presidio Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2010
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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