A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
NCT ID: NCT01247194
Last Updated: 2012-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-10-31
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.
NCT00671671
A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
NCT00445315
A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
NCT01928147
Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
NCT01651767
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
NCT00810758
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
PPI-461 50 mg
or placebo
PPI-461
capsule, oral, once daily for 3 days
Placebo
capsules, oral, once daily for 3 days
Cohort B
PPI-461 100 mg
or placebo
PPI-461
capsule, oral, once daily for 3 days
Placebo
capsules, oral, once daily for 3 days
Cohort C
PPI-461 200 mg
or placebo
PPI-461
capsule, oral, once daily for 3 days
Placebo
capsules, oral, once daily for 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PPI-461
capsule, oral, once daily for 3 days
Placebo
capsules, oral, once daily for 3 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Presidio Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nathaniel Brown, M.D.
Role: STUDY_DIRECTOR
Presidio Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution
Sacramento, California, United States
Local institution
San Francisco, California, United States
Local institution
Aarhus, , Denmark
Local institution
Copenhagen, , Denmark
Local institution
Herlev, , Denmark
Local institution
Hvidovre, , Denmark
Local institution
Kolding, , Denmark
Local institution
Odense, , Denmark
Local institution
London, , United Kingdom
Local institution
London, , United Kingdom
Local institution
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-021510-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PPI-461-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.