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CLINICAL STUDIES

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

Dag Nilsson, MD, PhD, Johan Wemer, MD, RPh, PhD, Yi-Fang Cheng, MD, PhD, Ingalill Reinholdsson, Gunnar Englund, ED, Nils Egberg, MD, PhD and Sam Schulman, MD, PhD

From Medical Neuroscience (Dr Nilsson), Clinical Pharmacology (Dr Cheng), Clinical Development (Mr Reinholdsson), AstraZeneca R&D Södertälje, Södertälje, Sweden; Xendo Drug Development Services, Groningen, the Netherlands (Dr Wemer); Royal Institute of Technology, Stockholm, Sweden (Dr Englund); the Department of Molecular Medicine and Surgery, Karolinska University Hospital, Stockholm, Sweden (Dr Egberg); and the Department of Medicine, McMaster University, Hamilton, Canada (Dr Schulman).

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.

Key Words: Acute ischemic stroke • bleeding • neuroprotectant • NXY-059 • pharmacokinetics

Address for reprints: Address for correspondence: Dag Nilsson, MD, PhD, Medical Neuroscience, AstraZeneca R&D, Södertälje, SE-151 85, Sweden; e-mail: dag.nilsson{at}astrazeneca.com.






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