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Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01806077
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : April 21, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Sinai Hospital of Baltimore
Information provided by (Responsible Party):
Tufts Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Vascular Disease Coronary Artery Disease Risk Factors Multiple Drug: PZ-128 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Demonstration of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Antiplatelet Effect of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
Study Start Date : April 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PZ-128 Drug: PZ-128
Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Pharmacokinetic profile of PZ-128 [ Time Frame: Assessments will be done up to 7 days post dosing ]
  2. Evaluate inhibition of ex vivo platelet function in response to multiple agonists [ Time Frame: Assessments will be done up to 7 days post dosing ]
  3. Correlate PZ-128 plasma levels with inhibition of platelet aggregation [ Time Frame: Assessments will be done up to 7 days post dosing ]
  4. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01806077

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United States, Maryland
Sinai Hospital of Baltimore (Sinai Center for Thrombosis Research)
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Sinai Hospital of Baltimore
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Principal Investigator: Paul A. Gurbel, MD Sinai Hospital of Baltimore (Sinai Center for Thrombosis Research)
Study Director: Athan Kuliopulos, MD, PhD Tufts Medical Center (Hemostasis and Thrombosis Laboratory)
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Responsible Party: Tufts Medical Center Identifier: NCT01806077    
Other Study ID Numbers: TMC-A2012-04
P50HL110789 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Keywords provided by Tufts Medical Center:
Cardiovascular Diseases
Vascular Diseases
Coronary Artery Disease
Coronary Disease
Platelet Aggregation Inhibitors
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases