NXY-059 does not affect bleeding time in healthy volunteers: A randomized, double-blind, placebo-controlled, 3-period crossover phase I study
2007 (English)In: Journal of clinical pharmacology, ISSN 0091-2700, E-ISSN 1552-4604, Vol. 47, no 2, 264-272 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2007. Vol. 47, no 2, 264-272 p.
acute ischemic stroke, bleeding, neuroprotectant, NXY-059, pharmacokinetics, acute ischemic-stroke, tissue-plasminogen activator, cerebral-ischemia, desmopressin, transient, occlusion, trials, agent, rat
IdentifiersURN: urn:nbn:se:kth:diva-16362DOI: 10.1177/0091270006293752ISI: 000243911700014ScopusID: 2-s2.0-33846437429OAI: oai:DiVA.org:kth-16362DiVA: diva2:334404
QC 201005252010-08-052010-08-05Bibliographically approved