Vascular DiseasePhase 1NCT01806077
Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
A Phase 1 study testing PZ-128 in people with Vascular Disease and Coronary Artery Disease Risk Factors Multiple, run by Tufts Medical Center at 1 site in United States.
Trial summary
This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1) in subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vascular Disease, Coronary Artery Disease Risk Factors Multiple
- What is being tested?
- PZ-128
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between the ages of 18 to 75 with documented vascular disease (peripheral vascular disease, carotid artery disease or coronary artery disease) or 2 or more coronary artery risk factors.
- Women of childbearing potential must have a negative pregnancy test prior to enrollment and immediately before drug administration and agree to use two methods of effective barrier contraception, or a hormonal contraceptive to prevent pregnancy throughout the study.
- The subject is able to read and give written informed consent and has signed and dated an informed consent document and authorization permitting release of personal health information approved by the Investigator's Institutional Review Board (IRB).
Who cannot join
- The subject has participated in an investigational drug study within the last 30 days.
- The subject has a medical or surgical condition that may impair drug absorption or metabolism.
- Anticoagulants, P2Y12 inhibitors, nonsteroidal antiinflammatory drugs (no more than three times a week) or any other drug that the investigator deems to have potential interaction with platelets or PAR-1 receptor inhibition are prohibited from 2 weeks prior to study drug dosing through 2 weeks post dosing. Aspirin is allowed.
- The subject has previous history of anaphylaxis to drugs or any environmental stimuli including foods or hymenoptera (e.g., ants, bees, wasps) stings.
- Asthma requiring bronchodilator/inhaler therapy.
- Currently smoking ≥2 pack/day.
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- Herbal supplements (i.e., Fish Oil/Omega-3, St. John's Wart, Ginseng, Garlic, Ginkgo, Saw Palmetto, Echinacea, Yohimbine, Licorice, and Black Cohosh) are prohibited from 1 week prior to dosing through 24 hours post dosing.
- Prior history or clinical suspicion of cerebral vascular malformations, intracranial tumor, transient ischemic attack, stroke, gastric ulcers and any form of bleeding disorder.
- Prior history of myocardial infarction within the last 3 months or unstable angina.
- Thrombocytopenia defined as a platelet count of <130,000/mm3 or low hematocrit defined as <30%.
- Renal function: serum creatinine >1.5 x ULN. However, subjects with an estimated creatinine clearance eGFR ≥60 mL/min, calculated using the Cockcroft-Gault formula, are eligible.
- Liver enzymes ≥ 3 x upper limit of normal.
- Alcohol consumption within 48 hrs prior to dosing, and for the duration of the in-house study period.
- Evidence of history of substance or alcohol abuse at screening, including positive urine test results for drugs or positive breath test for alcohol.
- Uncontrolled hypertension or hypotension defined as a sustained supine systolic pressure >160 mmHg or <100 mmHg; or a diastolic pressure >90 mmHg or < 50 mmHg.
- International normalized ratio (INR) >1.5
- Poor venous access (i.e., insufficient for intravenous drug delivery).
- History of hepatitis or HIV.
- The subject has undergone an invasive surgical procedure within the last 3 months, is anticipating one during the course of their study participation or is planning to have one within 1 month post dosing with the study drug.
- The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the Investigator increase the risk of the subject's participation in the study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy or any unexplained blackouts, previous hypersensitivity to drugs, and severe asthma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Hospital of Baltimore (Sinai Center for Thrombosis Research)
Baltimore, Maryland, 21215
About this study
Official title: Demonstration of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Antiplatelet Effect of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1) in subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk factors.
- Being tested
- PZ-128
- Keywords
- Cardiovascular Diseases, Vascular Diseases, Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Platelet Aggregation Inhibitors
- Medical subject headings
- Vascular Diseases, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PZ-128Drug
Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| PZ-128 | Experimental | Not described Receives: Drug: PZ-128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Participants Experience with Safety and Tolerability
Safety and tolerability of a single dose of PZ-128 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, pulmonary function tests and electrocardiograms (ECGs).
Measured: 30 days after drug infusion
Secondary outcomes (4)
Pharmacokinetic profile of PZ-128
Measured: Assessments will be done up to 7 days post dosing
Evaluate inhibition of ex vivo platelet function in response to multiple agonists
Measured: Assessments will be done up to 7 days post dosing
Correlate PZ-128 plasma levels with inhibition of platelet aggregation
Measured: Assessments will be done up to 7 days post dosing
Evaluate changes in clotting characteristics at each dose level of PZ-128 relative to baseline
Measured: Assessments will be done up to 7 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Sinai Hospital of Baltimore
- Responsible party
- Sponsor
- Investigators
- Paul A. Gurbel, MD, Principal investigator, Sinai Hospital of Baltimore (Sinai Center for Thrombosis Research)Athan Kuliopulos, MD, PhD, Study director, Tufts Medical Center (Hemostasis and Thrombosis Laboratory)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806077
- Sponsor's protocol ID
- TMC-A2012-04
- Other IDs
- P50HL110789
- Status last verified
- Apr 2016
- First submitted
- 1 Mar 2013
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gurbel PA, Bliden KP, Turner SE, Tantry US, Gesheff MG, Barr TP, Covic L, Kuliopulos A. Cell-Penetrating Pepducin Therapy Targeting PAR1 in Subjects With Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2016 Jan;36(1):189-97. doi: 10.1161/ATVBAHA.115.306777.
PubMed 26681756
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Antiplatelet Effect of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
- ClinicalTrials.gov ID
- NCT01806077
- Acronym / sponsor ID
- TMC-A2012-04
- Keywords
- Cardiovascular Diseases, Vascular Diseases, Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Platelet Aggregation Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Sinai Hospital of Baltimore
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Mar 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.
This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1) in subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PZ-128 | Experimental | Drug: PZ-128 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects between the ages of 18 to 75 with documented vascular disease (peripheral vascular disease, carotid artery disease or coronary artery disease) or 2 or more coronary artery risk factors.
- Women of childbearing potential must have a negative pregnancy test prior to enrollment and immediately before drug administration and agree to use two methods of effective barrier contraception, or a hormonal contraceptive to prevent pregnancy throughout the study.
- The subject is able to read and give written informed consent and has signed and dated an informed consent document and authorization permitting release of personal health information approved by the Investigator's Institutional Review Board (IRB).
Key exclusion criteria (20 listed)
- The subject has participated in an investigational drug study within the last 30 days.
- The subject has a medical or surgical condition that may impair drug absorption or metabolism.
- Anticoagulants, P2Y12 inhibitors, nonsteroidal antiinflammatory drugs (no more than three times a week) or any other drug that the investigator deems to have potential interaction with platelets or PAR-1 receptor inhibition are prohibited from 2 weeks prior to study drug dosing through 2 weeks post dosing. Aspirin is allowed.
- The subject has previous history of anaphylaxis to drugs or any environmental stimuli including foods or hymenoptera (e.g., ants, bees, wasps) stings.
- Asthma requiring bronchodilator/inhaler therapy.
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 |
|---|---|---|
| PZ-128Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion | Drug | PZ-128 |
Primary outcome
Summary of Participants Experience with Safety and Tolerability
Time frame: 30 days after drug infusion
Safety and tolerability of a single dose of PZ-128 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, pulmonary function tests and electrocardiograms (ECGs).
4 secondary outcomes
Pharmacokinetic profile of PZ-128
Time frame: Assessments will be done up to 7 days post dosing
Evaluate inhibition of ex vivo platelet function in response to multiple agonists
Time frame: Assessments will be done up to 7 days post dosing
Correlate PZ-128 plasma levels with inhibition of platelet aggregation
Time frame: Assessments will be done up to 7 days post dosing
Evaluate changes in clotting characteristics at each dose level of PZ-128 relative to baseline
Time frame: Assessments will be done up to 7 days post dosing
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 21 Apr 2016.
- Background: PubMed 26681756Gurbel PA, Bliden KP, Turner SE, Tantry US, Gesheff MG, Barr TP, Covic L, Kuliopulos A. Cell-Penetrating Pepducin Therapy Targeting PAR1 in Subjects With Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2016 Jan;36(1):189-97. doi: 10.1161/ATVBAHA.115.306777.
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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.
Paul A. Gurbel, MD principal investigator
Sinai Hospital of Baltimore (Sinai Center for Thrombosis Research)
Athan Kuliopulos, MD, PhD study director
Tufts Medical Center (Hemostasis and Thrombosis Laboratory)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PZ-128 in people with Vascular Disease and Coronary Artery Disease Risk Factors Multiple, run by Tufts Medical Center at 1 site in United States.
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 3 inclusion and 20 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Summary of Participants Experience with Safety and Tolerability (time frame: 30 days after drug infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01806077, which also lists 1 linked publication.
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 21 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.