PER977 administration following a single dose of enoxaparin
Single escalating doses of PER977 from 100 to 300 mg, of 25 mg PER977 x 4 doses will be administered following administration of enoxaparin. Serial pharmacokinetic and pharmacodynamic assessments ( whole blood clotting time) will be performed. Adverse events will be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
40
reversal of edoxaban-induced anticoagulation
Reversal of edoxaban-induced anticoagulation
Quintiles
Overland Park, Kansas, United States
Number of adverse events
Assessment of the number of subjects who experience adverse events and the number and type of adverse events
Time frame: 1 day
Reversal of enoxaparin anticoagulation
Measurement of the degree of change in whole blood clotting time and the proportion of subjects who achieve complete or partial reversal of anticoagulation
Time frame: 1 day
Pharmacokinetics of enoxaparin
Measurement of the pharmacokinetic characteristics of enoxaparin
Time frame: 1 day
Pharmacokinetics of PER977 and its metabolite
Measurement of the pharmacokinetic characteristics of PER977 and its metabolite
Time frame: 2 days
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