NCT01247194

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_1

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

7 months

First QC Date

November 22, 2010

Last Update Submit

February 1, 2012

Conditions

Chronic Genotype 1 Hepatitis C Virus Infection

Keywords

hepatitis CNS5AHCV RNA

Outcome Measures

Primary Outcomes (3)

  • 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)

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

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

  • PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations

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

Study Arms (3)

Cohort A

ACTIVE COMPARATOR

PPI-461 50 mg or placebo

Drug: PPI-461Drug: Placebo

Cohort B

ACTIVE COMPARATOR

PPI-461 100 mg or placebo

Drug: PPI-461Drug: Placebo

Cohort C

ACTIVE COMPARATOR

PPI-461 200 mg or placebo

Drug: PPI-461Drug: Placebo

Interventions

PPI-461DRUG

capsule, oral, once daily for 3 days

Cohort ACohort BCohort C
PlaceboDRUG

capsules, oral, once daily for 3 days

Cohort ACohort BCohort C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Local Institution

Sacramento, California, 95817, United States

Location

Local institution

San Francisco, California, 94115, United States

Location

Local institution

Aarhus, Denmark

Location

Local institution

Copenhagen, Denmark

Location

Local institution

Herlev, Denmark

Location

Local institution

Hvidovre, Denmark

Location

Local institution

Kolding, Denmark

Location

Local institution

Odense, Denmark

Location

Local institution

London, NW3 2QG, United Kingdom

Location

Local institution

London, SE5 9RS, United Kingdom

Location

Local institution

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Nathaniel Brown, M.D.

    Presidio Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 24, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

US(2)DK(6)GB(3)