Anticoagulation Reversal Clinical Trial
Official title:
Phase II Randomized, Sequential Group, Evaluation of Ascending Reversal Doses of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban Following PER977 Reversal
This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of subjects with edoxaban following reversal by PER977 and will identify a dose regimen of PER977 that reverses the effects of edoxaban for up to 21 hours.
This is a randomized, single-blind, sequential group, ascending PER977 reversal dose study in
healthy volunteers. Subjects will be randomized in a 4:1 ratio to receive either PER977 or
placebo. All subjects will receive a single dose of edoxaban 60 mg on Days 1-4. On Days 3 and
4, study drug will be administered 3 hours following edoxaban. Beginning with Cohort 2, study
drug will be administered only to those subjects with a minimum increase in whole blood
clotting time >25% above baseline.
Pharmacokinetic assessment of PER977 and tis metabolite, and edoxaban and its metabolite will
be performed. Pharmacodynamic assessment of WBCT and Point of Care prothrombin time will be
performed. Safety will be assessed throughout the study.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03473132 -
Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)
|
Phase 4 |