Hepatitis C, ChronicPhase 1NCT01448200
A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1
A Phase 1 study testing PPI-668 in people with Hepatitis C, Chronic, run by Presidio Pharmaceuticals, Inc. at 7 sites in 3 countries.
Trial summary
PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- PPI-668
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Oct 2011to Nov 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 65 years of age. Female patients must be surgically sterile or two years post-menopausal.
- Body Mass Index (BMI) 18 - 35 kg/m2
- In good health, in the judgment of the Principal Investigator
- Able and willing to comply with all protocol requirements and to sign an informed consent.
Who cannot join
- Seropositive for HIV antibody, or HBV surface antigen (HBsAg) at Screen. Volunteer subjects for Part I must also be negative for HCV antibody.
- Any medical condition that may interfere with the absorption, distribution or elimination of study drug (PPI-668), or with the clinical and laboratory assessments in this study.
- Poorly controlled or unstable hypertension; or sustained systolic BP > 150 or diastolic BP > 95 at Screen.
- History of Diabetes Mellitus treated with insulin or hypoglycemic agents
- History of alcohol abuse or illicit drug use which, in the investigator's judgment, could interfere with a patient's compliance, with the protocol requirements or with the safety or efficacy assessments of the study
- History of malignancy unless the malignancy has been in complete remission and without additional medical or surgical interventions during the preceding three years
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- No clinically significant laboratory abnormalities at Screen for healthy volunteers in Part I. For Screen laboratory parameters for HCV patients in Part II, refer to the 'Additional Criteria for HCV Patients' below.
- Additional Key Entry Criteria for HCV patients (Part II):
- Clinical diagnosis of chronic hepatitis C, documented by:
- Clinical findings compatible with chronic hepatitis C, and absence of other known liver disease
- Seropositive for HCV antibody or HCV RNA at least once previously, and at Screen
- Serum HCV RNA > 5 log10 IU/mL at Screen, by the PCR assay at the central study laboratory
- HCV genotype-1 (1a or 1b, or non-subtypable genotype-1), or HCV genotype-2a or genotype-3a
- ALT must be <5 x ULN at screen
- No previous treatment with interferon, pegIFN, or ribavirin for genotype-1 patients
- No history of signs or symptoms of decompensated liver disease
- Any of the following laboratory values at Screening will be exclusionary for study participation:
- Hgb <11 g/dL in women or 12 g/dL in men.
- White blood cell count < 4,000/mm3.
- Absolute neutrophil count (ANC) < 1800 per mm3.
- Platelet count < 100,000 per mm3.
- Serum creatinine >ULN at the central study laboratory.
- Serum albumin < 3.4 g/dL.
- Total bilirubin > 2.0 mg/dL
- Clinically significant abnormality in the electrocardiograms (ECGs) at Screen
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
Investigational site
Costa Mesa, California
Investigational site
Sacramento, California
Investigational Site
San Antonio, Texas
Investigational site
San Francisco, California
New Zealand2 sites
Investigational site
Auckland
Investigational site
Christchurch
About this study
Official title: A Phase 1 Dose-Ranging Study to Assess the Safety, Pharmacokinetics and Antiviral Efficacy of PPI-668 in Healthy Volunteers and Patients With HCV Genotype-1 Infection
PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
- Conditions
- Hepatitis C, Chronic
- Being tested
- PPI-668, Placebo
- Keywords
- hepatitis C, NS5A inhibitor, Phase 1, genotype-1, genotype-2, genotype-3
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI-668Drug
capsules
PlaceboDrug
capsules
| Study group | Role | What they receive |
|---|---|---|
| Part I: single dose escalation in healthy volunteers | Experimental | There will be three sequential single dose cohorts:
Cohort A: PPI-668 dose D1 or placebo
Cohort B: PPI-668 dose D2 or placebo
Cohort C: PPI-668 dose D3 or placebo Receives: Drug: PPI-668; Drug: Placebo |
| Part I: multiple dose administration to healthy volunteers | Experimental | Upon completion of the single dose escalation phase, an additional cohort will receive repeat doses:
Cohort D: highest well-tolerated dose from Cohorts A-C or placebo once daily for five days Receives: Drug: PPI-668; Drug: Placebo |
| Part II: multiple dose escalation in HCV subjects | Experimental | Upon completion of Part I, there will be 3, and potentially 4, sequential cohorts of HCV patients:
Cohort E (genotype-1): PPI-668 dose E1 or placebo
Cohort F (genotype-1): PPI-668 dose E2 or placebo
Cohort G (genotype-1): PPI-668 dose E3 or placebo
Cohort H (genotype-1): if necessary for dose-response assessment; dose to be determined
Cohort I (genotype-2 or -3): PPI-668 dose E4 or placebo Receives: Drug: PPI-668; 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: Part I, up to day 12; and Part II, up to day 17
Secondary outcomes (2)
PPI-668 plasma levels
Measured: Part I, up to day 12; and Part II, up to day 17
serum HCV RNA levels
Measured: Part II, up to day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448200
- Sponsor's protocol ID
- PPI-668-101
- Status last verified
- Nov 2012
- First submitted
- 5 Oct 2011
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Ranging Study to Assess the Safety, Pharmacokinetics and Antiviral Efficacy of PPI-668 in Healthy Volunteers and Patients With HCV Genotype-1 Infection
- ClinicalTrials.gov ID
- NCT01448200
- Acronym / sponsor ID
- PPI-668-101
- Conditions
- Hepatitis C, Chronic
- Keywords
- hepatitis C, NS5A inhibitor, Phase 1, genotype-1, genotype-2, genotype-3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Presidio Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Oct 2011 (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.
PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I: single dose escalation in healthy volunteers | Experimental | Drug: PPI-668, Drug: PlaceboThere will be three sequential single dose cohorts: Cohort A: PPI-668 dose D1 or placebo Cohort B: PPI-668 dose D2 or placebo Cohort C: PPI-668 dose D3 or placebo |
| Part I: multiple dose administration to healthy volunteers | Experimental | Drug: PPI-668, Drug: PlaceboUpon completion of the single dose escalation phase, an additional cohort will receive repeat doses: Cohort D: highest well-tolerated dose from Cohorts A-C or placebo once daily for five days |
| Part II: multiple dose escalation in HCV subjects | Experimental | Drug: PPI-668, Drug: PlaceboUpon completion of Part I, there will be 3, and potentially 4, sequential cohorts of HCV patients: Cohort E (genotype-1): PPI-668 dose E1 or placebo Cohort F (genotype-1): PPI-668 dose E2 or placebo Cohort G (genotype-1): PPI-668 dose E3 or placebo Cohort H (genotype-1): if necessary for dose-response assessment; dose to be determined Cohort I (genotype-2 or -3): PPI-668 dose E4 or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, between 18 and 65 years of age. Female patients must be surgically sterile or two years post-menopausal.
- Body Mass Index (BMI) 18 - 35 kg/m2
- In good health, in the judgment of the Principal Investigator
- Able and willing to comply with all protocol requirements and to sign an informed consent.
Key exclusion criteria (25 listed)
- Seropositive for HIV antibody, or HBV surface antigen (HBsAg) at Screen. Volunteer subjects for Part I must also be negative for HCV antibody.
- Any medical condition that may interfere with the absorption, distribution or elimination of study drug (PPI-668), or with the clinical and laboratory assessments in this study.
- Poorly controlled or unstable hypertension; or sustained systolic BP > 150 or diastolic BP > 95 at Screen.
- History of Diabetes Mellitus treated with insulin or hypoglycemic agents
- History of alcohol abuse or illicit drug use which, in the investigator's judgment, could interfere with a patient's compliance, with the protocol requirements or with the safety or efficacy assessments of the study
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-668capsules | Drug | Part I: multiple dose administration to healthy volunteers, Part I: single dose escalation in healthy volunteers, Part II: multiple dose escalation in HCV subjects |
| Placebocapsules | Drug | Part I: multiple dose administration to healthy volunteers, Part I: single dose escalation in healthy volunteers, Part II: multiple dose escalation in HCV subjects |
Primary outcome
Safety and tolerability, as measured by clinical adverse events and laboratory assessments
Time frame: Part I, up to day 12; and Part II, up to day 17
2 secondary outcomes
PPI-668 plasma levels
Time frame: Part I, up to day 12; and Part II, up to day 17
serum HCV RNA levels
Time frame: Part II, up to day 17
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 16 Nov 2012.
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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, Inc.
7 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-668 in people with Hepatitis C, Chronic, run by Presidio Pharmaceuticals, Inc. at 7 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?
The sponsor lists 4 inclusion and 25 exclusion criteria. 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 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, New Zealand, Australia. 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: Part I, up to day 12; and Part II, up to day 17). 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 16 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.