Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
Completed · Phase 1
Conditions studied: Cardiovascular Disease
In brief
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.
Key facts
- Study ID
- NCT00099450
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 48
- Starts
- 2004-12-01
- Expected to finish
- 2005-03-01
- Last updated by the study team
- 2015-01-21
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Quintiles Phase I Services — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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