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

February 1, 2012 updated by: Presidio Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Local Institution
      • Copenhagen, Denmark
        • Local Institution
      • Herlev, Denmark
        • Local Institution
      • Hvidovre, Denmark
        • Local Institution
      • Kolding, Denmark
        • Local Institution
      • Odense, Denmark
        • Local Institution
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Local Institution
      • London, United Kingdom, SE5 9RS
        • Local Institution
      • London, United Kingdom, W2 1NY
        • Local Institution
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Local Institution
      • San Francisco, California, United States, 94115
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cohort A

PPI-461 50 mg

or placebo
Drug: PPI-461
capsule, oral, once daily for 3 days
Drug: Placebo
capsules, oral, once daily for 3 days
Active Comparator: Cohort B

PPI-461 100 mg

or placebo
Drug: PPI-461
capsule, oral, once daily for 3 days
Drug: Placebo
capsules, oral, once daily for 3 days
Active Comparator: Cohort C

PPI-461 200 mg

or placebo
Drug: PPI-461
capsule, oral, once daily for 3 days
Drug: Placebo
capsules, oral, once daily for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
up to Study Day 16 (14 days after the last PPI-461 dose)
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)
Up to Study Day 16 (14 days after the last PPI-461 dose)
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)
Up to Study Day 10 (8 days after the last PPI-461 dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Presidio Pharmaceuticals, Inc.

Investigators

  • Study Director: Nathaniel Brown, M.D., Presidio Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPI-461-102
  • 2010-021510-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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