Chronic Genotype 1 Hepatitis C Virus InfectionPhase 1NCT01247194
A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
A Phase 1 study testing PPI-461 in people with Chronic Genotype 1 Hepatitis C Virus Infection, run by Presidio Pharmaceuticals, Inc. at 11 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Genotype 1 Hepatitis C Virus Infection
- What is being tested?
- PPI-461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Oct 2010to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Denmark6 sites
Local institution
Aarhus
Local institution
Copenhagen
Local institution
Herlev
Local institution
Hvidovre
Local institution
Kolding
Local institution
Odense
United Kingdom3 sites
Local institution
London, NW3 2QG
Local institution
London, SE5 9RS
Local institution
London, W2 1NY
United States2 sites
Local Institution
Sacramento, California, 95817
Local institution
San Francisco, California, 94115
About this study
Official title: A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection
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.
- Being tested
- PPI-461, Placebo
- Keywords
- hepatitis C, NS5A, HCV RNA
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI-461Drug
capsule, oral, once daily for 3 days
PlaceboDrug
capsules, oral, once daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | PPI-461 50 mg
or placebo Receives: Drug: PPI-461; Drug: Placebo |
| Cohort B | Active comparator | PPI-461 100 mg
or placebo Receives: Drug: PPI-461; Drug: Placebo |
| Cohort C | Active comparator | PPI-461 200 mg
or placebo Receives: Drug: PPI-461; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability, as measured by clinical adverse events and laboratory assessments
Measured: up to Study Day 16 (14 days after the last PPI-461 dose)
Antiviral effects of PPI-461, as measured by HCV RNA levels
Measured: Up to Study Day 16 (14 days after the last PPI-461 dose)
PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations
Measured: Up to Study Day 10 (8 days after the last PPI-461 dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Genotype 1 Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathaniel Brown, M.D., Study director, Presidio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247194
- Sponsor's protocol ID
- PPI-461-102
- Other IDs
- 2010-021510-36
- Status last verified
- Feb 2012
- First submitted
- 22 Nov 2010
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Assess the Safety, Antiviral Efficacy and Pharmacokinetics of PPI-461 in Patients With HCV Genotype-1 Infection
- ClinicalTrials.gov ID
- NCT01247194
- Acronym / sponsor ID
- PPI-461-102
- Keywords
- hepatitis C, NS5A, HCV RNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Presidio Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Drug: PPI-461, Drug: PlaceboPPI-461 50 mg or placebo |
| Cohort B | Active comparator | Drug: PPI-461, Drug: PlaceboPPI-461 100 mg or placebo |
| Cohort C | Active comparator | Drug: PPI-461, Drug: PlaceboPPI-461 200 mg or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI-461capsule, oral, once daily for 3 days | Drug | Cohort A, Cohort B, Cohort C |
| Placebocapsules, oral, once daily for 3 days | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Brown, M.D. study director
Presidio Pharmaceuticals
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PPI-461 in people with Chronic Genotype 1 Hepatitis C Virus Infection, run by Presidio Pharmaceuticals, Inc. at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark, United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.