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NXY‐059 Does Not Affect Bleeding Time in Healthy Volunteers: A Randomized, Double‐Blind, Placebo‐Controlled, 3‐Period Crossover Phase I Study
Author(s) -
Nilsson Dag,
Wemer Johan,
Cheng YiFang,
Reinholdsson Ingalill,
Englund Gunnar,
Egberg Nils,
Schulman Sam
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006293752
Subject(s) - placebo , crossover study , medicine , hemostasis , anesthesia , modified rankin scale , double blind , bleeding time , stroke (engine) , randomized controlled trial , platelet , platelet aggregation , cardiology , ischemia , ischemic stroke , pathology , mechanical engineering , alternative medicine , engineering
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 μmol/L, NXY‐059 was well tolerated, with no major safety concerns identified. In conclusion, NXY‐059 does not appear to affect primary hemostasis.