Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:9/28/2018
Start Date:December 2012
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect Factor Xa (fXa) Inhibitors in Healthy Volunteers.

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.

A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445
after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in
healthy volunteers.

Inclusion Criteria:

- Healthy men or women between the ages of 18 and 45 years old

Exclusion Criteria:

- 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.
We found this trial at
1
site
Clinical Trial Facility in Tempe Arizona
Tempe, Arizona 85284
?
mi
from
Tempe, AZ
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