NXY-059 does not affect bleeding time in healthy volunteers : A randomized, double-blind, placebo-controlled, 3-period crossover phase I study

• NXY-059 is a novel free radical-trapping neuroprotectant that reduces infarct size and preserves brain function in animal models of acute ischemic stroke. It is the first neuroprotectant to demonstrate a reduction in global disability in a phase III clinical trial, as measured by the modified Rankin Scale. Any effect of NXY-059 on hemostasis may be important when treating stroke patients. This phase I randomized, double-blind, placebo-controlled, 3-period crossover study compared the effect of NXY-059, desmopressin, and placebo on bleeding time, platelet aggregation, and adhesion in 30 healthy volunteers. NXY-059 did not prolong bleeding time compared with placebo: mean (SD) time for NXY-059, 369.5 seconds (125.0 seconds) versus placebo, 369.1 seconds (136.0 seconds). There were no significant effects on platelet aggregation or adhesion. At a mean unbound plasma concentration (Cu-ss) of 335 mu mol/L, NXY-059 was well tolerated, with no major safety concerns identified. In conclusion, NXY-059 does not appear to affect primary hemostasis.

Nyckelord

acute ischemic stroke

bleeding

neuroprotectant

NXY-059

pharmacokinetics

acute ischemic-stroke

tissue-plasminogen activator

cerebral-ischemia

desmopressin

transient

occlusion

trials

agent

rat

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