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

Chronic Genotype 1 Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247194
• Other study ID #: PPI-461-102
• Secondary ID: 2010-021510-36
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2010
• Last updated: February 1, 2012
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Presidio Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyUnited States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Genotype 1 Hepatitis C Virus Infection
• Hepatitis C
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Local institution	Aarhus
Denmark	Local institution	Copenhagen
Denmark	Local institution	Herlev
Denmark	Local institution	Hvidovre
Denmark	Local institution	Kolding
Denmark	Local institution	Odense
United Kingdom	Local institution	London
United Kingdom	Local institution	London
United Kingdom	Local institution	London
United States	Local Institution	Sacramento	California
United States	Local institution	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Presidio Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	Antiviral effects of PPI-461, as measured by HCV RNA levels		Up to Study Day 16 (14 days after the last PPI-461 dose)	No
Primary	PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations		Up to Study Day 10 (8 days after the last PPI-461 dose)	No