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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01247194
First received: November 22, 2010
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Chronic Genotype 1 Hepatitis C Virus Infection
Drug: PPI-461
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection

Resource links provided by NLM:


Further study details as provided by Presidio Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247194

Locations
United States, California
Local Institution
Sacramento, California, United States, 95817
Local institution
San Francisco, California, United States, 94115
Denmark
Local institution
Aarhus, Denmark
Local institution
Copenhagen, Denmark
Local institution
Herlev, Denmark
Local institution
Hvidovre, Denmark
Local institution
Kolding, Denmark
Local institution
Odense, Denmark
United Kingdom
Local institution
London, United Kingdom, NW3 2QG
Local institution
London, United Kingdom, W2 1NY
Local institution
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Presidio Pharmaceuticals, Inc.
Investigators
Study Director: Nathaniel Brown, M.D. Presidio Pharmaceuticals
  More Information

No publications provided

Responsible Party: Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01247194     History of Changes
Other Study ID Numbers: PPI-461-102, 2010-021510-36
Study First Received: November 22, 2010
Last Updated: February 1, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Presidio Pharmaceuticals, Inc.:
hepatitis C
NS5A
HCV RNA

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis
Hepatitis C
Infection
Virus Diseases
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections

ClinicalTrials.gov processed this record on November 27, 2014