Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers

Study Overview
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Brief Summary
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The objectives of this study are to look at the safety and tolerability of the experimental drug, how people process the drug, how the drug affects people, and to identify a dose or doses to study in subsequent future studies.

Detailed Description
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The purposes of this trial are to determine if administration of INS50589 Intravenous Infusion is well tolerated, to determine the pharmacological effects of INS50589 at different doses, and to identify an appropriate dose for later efficacy studies. More specifically, the objectives are to: Evaluate safety and tolerability Evaluate pharmacokinetics of INS50589 and its major metabolite(s) Evaluate effects of INS50589 on platelet function at various dose levels Evaluate potential relationship between plasma concentrations of INS50589 and various pharmacodynamic endpoints Identify one or more dose levels of INS50589 for future studies

Official Title
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Single-Center, Open-Labeled Dose Escalation Followed by Randomized, Double-Blind, Placebo-Controlled Cohort Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: INS50589 Intravenous Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2 and body weight no greater than 120 kg. If female, must not be pregnant or lactating, and if of childbearing potential or sexually active, must use acceptable method of birth control. Exclusion Criteria: Have clinically significant acute or chronic disease (e.g., coronary artery disease, diabetes, chronic renal insufficiency, asthma). Have major surgery within eight weeks of dosing. Have overt viral illness within four weeks of dosing. Have tendency or history in family of tendency for bleeding. Have clinically significant abnormalities on clinical laboratory tests (chemistry, hematology, urinalysis). Have taken aspirin or any other non-steroidal anti-inflammatory drug (NSAID) within 10 days prior to admission to study facility. Have ever taken or received any of the following for medical conditions: (antiplatelet compounds including clopidogrel, ticlopidine, dipyridamole, tirofiban, eptifibatide, abciximab, adenosine, and prostacyclin) or (anticoagulants including vitamin K antagonists, thrombin inhibitors, heparins, hirudin or related compounds, argatroban and factor Xa inhibitors) Have a clinically significant ECG abnormality.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INS50589 Intravenous Infusion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot study - not specified |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleeding, blood transfusion, surgeries