Status:
COMPLETED
Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 identi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2005
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00099450
Start Date
December 1 2004
End Date
March 1 2005
Last Update
January 21 2015
Active Locations (1)
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1
Quintiles Phase I Services
Lenexa, Kansas, United States, 66219