NXY-059 does not affect bleeding time in healthy volunteers: a randomized, double-blind, placebo-controlled, 3-period crossover phase I study
| Autor: | Nils Egberg, Dag Nilsson, Johan Wemer, Gunnar Englund, Sam Schulman, Yi-Fang Cheng, Ingalill Reinholdsson |
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| Rok vydání: | 2007 |
| Předmět: |
Male
Bleeding Time Platelet Aggregation Placebo Tissue plasminogen activator Hemostatics Platelet Adhesiveness Pharmacokinetics Double-Blind Method Bleeding time Occlusion medicine Humans Pharmacology (medical) Deamino Arginine Vasopressin cardiovascular diseases Desmopressin Acute ischemic stroke Blood Coagulation Pharmacology Cross-Over Studies medicine.diagnostic_test business.industry Benzenesulfonates Phase i study Neuroprotective Agents Anesthesia business medicine.drug |
| Zdroj: | Journal of clinical pharmacology. 47(2) |
| ISSN: | 0091-2700 |
| Popis: | 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 micromol/L, NXY-059 was well tolerated, with no major safety concerns identified. In conclusion, NXY-059 does not appear to affect primary hemostasis. |
| Databáze: | OpenAIRE |
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