Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests
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The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
Condition or disease
Biological: PRT064445Biological: Placebo
A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy men or women between the ages of 18 and 45 years old
History (including family history) or symptoms of, or risk factors for bleeding
History (including family history) of or risk factors for a hypercoagulable or thrombotic condition
Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants
History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing.