Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 9/27/2018 |
| Start Date: | June 2012 |
| End Date: | October 2012 |
A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote
This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose
study of PRT064445 or its matching placebo, in healthy subjects.
study of PRT064445 or its matching placebo, in healthy subjects.
Inclusion Criteria:
- Healthy men or women between the ages of 18 and 50 years old, inclusive
- BMI 19-32 and weighs at least 60kgs
Exclusion Criteria:
- History or symptoms of bleeding problems or thrombotic conditions
- Clinically significant medical history
- Major surgery, severe trauma, or bone fracture within 3 months
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