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

Primary Purpose

Chronic Genotype 1 Hepatitis C Virus Infection

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PPI-461
Placebo
Sponsored by
Presidio Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Genotype 1 Hepatitis C Virus Infection focused on measuring hepatitis C, NS5A, HCV RNA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Local Institution
  • Local institution
  • Local institution
  • Local institution
  • Local institution
  • Local institution
  • Local institution
  • Local institution
  • Local institution
  • Local institution
  • Local institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

PPI-461 50 mg or placebo

PPI-461 100 mg or placebo

PPI-461 200 mg or placebo

Outcomes

Primary Outcome Measures

Safety and tolerability, as measured by clinical adverse events and laboratory assessments
Antiviral effects of PPI-461, as measured by HCV RNA levels
PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations

Secondary Outcome Measures

Full Information

First Posted
November 22, 2010
Last Updated
February 1, 2012
Sponsor
Presidio Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01247194
Brief Title
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

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Presidio Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Genotype 1 Hepatitis C Virus Infection
Keywords
hepatitis C, NS5A, HCV RNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Active Comparator
Arm Description
PPI-461 50 mg or placebo
Arm Title
Cohort B
Arm Type
Active Comparator
Arm Description
PPI-461 100 mg or placebo
Arm Title
Cohort C
Arm Type
Active Comparator
Arm Description
PPI-461 200 mg or placebo
Intervention Type
Drug
Intervention Name(s)
PPI-461
Intervention Description
capsule, oral, once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules, oral, once daily for 3 days
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Brown, M.D.
Organizational Affiliation
Presidio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Local institution
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Local institution
City
Aarhus
Country
Denmark
Facility Name
Local institution
City
Copenhagen
Country
Denmark
Facility Name
Local institution
City
Herlev
Country
Denmark
Facility Name
Local institution
City
Hvidovre
Country
Denmark
Facility Name
Local institution
City
Kolding
Country
Denmark
Facility Name
Local institution
City
Odense
Country
Denmark
Facility Name
Local institution
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Local institution
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local institution
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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