Hepatitis C, ChronicPhase 1NCT01928147
A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
A Phase 1 study testing PPI-383 in people with Hepatitis C, Chronic, run by Presidio Pharmaceuticals, Inc. at 6 sites in 2 countries.
Trial summary
PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days (Part I of the… 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-383
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Aug 2013to Nov 2015
- 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
Part I volunteers (single and multiple dose) - key inclusion criteria
- Healthy males
- Age 18 to 55 years
- Body mass index (BMI)18 to 32 kg/m2
Part II patients- key inclusion criteria
- Males, or females of non-childbearing potential
- Age 18 to 65 years
- Chronic hepatitis C, and absence of other known liver disease
- Seropositive for HCV antibody (HCV Ab) or HCV RNA at least once previously
- Seropositive for HCV Ab at screening
- Serum HCV RNA > 5 log10 IU/mL at screening
- HCV gt-1
- Treatment-naïve for hepatitis C:
- BMI 18 to 35 kg/m2
- Otherwise in good health, without severe or clinically significant chronic or recurrent conditions requiring frequent medical intervention or continual pharmacologic management, except for anti-hypertensive use
- No medical or psychosocial conditions that would potentially interfere with the subject's ability to comply with the study assessments or visit schedule.
Part II patients - key exclusion criteria
- Seropositive for human immunodeficiency virus (HIV) antibody or hepatitis B virus (HBV) surface antigen (HBsAg)
- Signs or symptoms of decompensated liver disease
- Evidence of cirrhosis or hepatocellular carcinoma
- Diabetes Mellitus treated with insulin or hypoglycemic agents
- Asthma requiring hospital admission within the preceding 12 months
- History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements
- Any of the following laboratory values at screening
- Haemoglobin (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 > upper limit of normal (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 screening
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom5 sites
Investigational site
London, NW3 2QG
Investigational site
London, SE5 9RS
Investigational site
London, UE1 2AD
Investigational site
London, W2 1NY
Investigational site
Nottingham
About this study
Official title: A Phase Ia and Ib Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Antiviral Efficacy of PPI-383 in Healthy Adults and Hepatitis C Patients
PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 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-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 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-383, Placebo
- Keywords
- NS5B polymerase inhibitor, Phase 1, Genotype 1
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI-383Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PPI-383 single dose escalation in healthy volunteers | Experimental | There will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included. Receives: Drug: PPI-383; Drug: Placebo |
| PPI-383 multiple doses in healthy volunteers | Experimental | Upon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens Receives: Drug: PPI-383; Drug: Placebo |
| PPI-383 multiple dose escalation in HCV Subjects | Experimental | Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients Receives: Drug: PPI-383; 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-383 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 posted23 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionNov 2015
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
- 114 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
- NCT01928147
- Sponsor's protocol ID
- PPI-383-101
- Status last verified
- Nov 2015
- First submitted
- 19 Aug 2013
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia and Ib Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Antiviral Efficacy of PPI-383 in Healthy Adults and Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT01928147
- Acronym / sponsor ID
- PPI-383-101
- Conditions
- Hepatitis C, Chronic
- Keywords
- NS5B polymerase inhibitor, Phase 1, Genotype 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Presidio Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Aug 2013 (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-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 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-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 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 |
|---|---|---|
| PPI-383 single dose escalation in healthy volunteers | Experimental | Drug: PPI-383, Drug: PlaceboThere will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included. |
| PPI-383 multiple doses in healthy volunteers | Experimental | Drug: PPI-383, Drug: PlaceboUpon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens |
| PPI-383 multiple dose escalation in HCV Subjects | Experimental | Drug: PPI-383, Drug: PlaceboUpon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- 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-383 | Drug | PPI-383 multiple dose escalation in HCV Subjects, PPI-383 multiple doses in healthy volunteers, PPI-383 single dose escalation in healthy volunteers |
| Placebo | Drug | PPI-383 multiple dose escalation in HCV Subjects, PPI-383 multiple doses in healthy volunteers, PPI-383 single dose escalation in healthy volunteers |
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-383 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 26 Nov 2015.
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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
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PPI-383 in people with Hepatitis C, Chronic, run by Presidio Pharmaceuticals, Inc. at 6 sites in 2 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 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Mauritius. 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 26 Nov 2015.