Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
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ClinicalTrials.gov Identifier: NCT01806077 |
Recruitment Status
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Completed
First Posted
: March 7, 2013
Last Update Posted
: April 21, 2016
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Sponsor:
Tufts Medical Center
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Sinai Hospital of Baltimore
Information provided by (Responsible Party):
Tufts Medical Center
Tracking Information | |||||||
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First Submitted Date ICMJE | March 1, 2013 | ||||||
First Posted Date ICMJE | March 7, 2013 | ||||||
Last Update Posted Date | April 21, 2016 | ||||||
Study Start Date ICMJE | April 2013 | ||||||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01806077 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors | ||||||
Official Title ICMJE | Demonstration of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Antiplatelet Effect of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 | ||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: PZ-128
Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion |
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Study Arms | Experimental: PZ-128
Intervention: Drug: PZ-128 |
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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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
32 | ||||||
Original Estimated Enrollment ICMJE |
34 | ||||||
Actual Study Completion Date | November 2014 | ||||||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01806077 | ||||||
Other Study ID Numbers ICMJE | TMC-A2012-04 P50HL110789 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Tufts Medical Center | ||||||
Study Sponsor ICMJE | Tufts Medical Center | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Tufts Medical Center | ||||||
Verification Date | April 2016 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |