Demonstration of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Antiplatelet Effect of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors

Tufts Medical Center1 site in 1 country32 target enrollmentApril 2013

ConditionsVascular Disease Coronary Artery Disease Risk Factors Multiple

InterventionsPZ-128

DrugsPZ-128

Overview

Phase: Phase 1
Intervention: PZ-128
Conditions: Vascular Disease
Sponsor: Tufts Medical Center
Enrollment: 32
Locations: 1
Primary Endpoint: Summary of Participants Experience with Safety and Tolerability
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

November 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tufts Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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%.

Arms & Interventions

PZ-128

Intervention: PZ-128

Outcomes

Primary Outcomes

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 Outcomes

Correlate PZ-128 plasma levels with inhibition of platelet aggregation(Assessments will be done up to 7 days post dosing)
Pharmacokinetic profile of PZ-128(Assessments will be done up to 7 days post dosing)
Evaluate inhibition of ex vivo platelet function in response to multiple agonists(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(Assessments will be done up to 7 days post dosing)