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 (Cuss) of 335 μmol/L, NXY‐059 was well tolerated, with no major safety concerns identified. In conclusion, NXY‐059 does not appear to affect primary hemostasis.

NXY‐059 Does Not Affect Bleeding Time in Healthy Volunteers: A Randomized, Double‐Blind, Placebo‐Controlled, 3‐Period Crossover Phase I Study Journal Articles