Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors (NCT01806077) | Clinical Trial Compass
CompletedPhase 1
Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
United States32 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
* Cu…
What they're measuring
1
Summary of Participants Experience with Safety and Tolerability