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NXY-059 Does Not Significantly Interact With Furosemide in Healthy Volunteers

From AstraZeneca R&D Södertälje, Södertälje, Sweden (Dr Strid); AstraZeneca R&D Södertälje, Medical Neuroscience, Södertälje, Sweden (Dr Nilsson); Borgå PK Consulting, S-211 16 Malmö, Sweden (Dr Borgå); Xendo Drug Development Services, Groningen, the Netherlands (Dr Wemer); and Quintiles AB, S-753 23 Uppsala, Sweden (Professor Grahnén).

NXY-059 is a free radical-trapping neuroprotectant that reduces infarct size and preserves brain function in animal models of acute ischemic stroke. Acute ischemic stroke patients receiving NXY-059 may also be exposed to diuretics for treatment of heart failure or hypertension. NXY-059 and furosemide are partly eliminated by active tubular secretion via an organic anion transporter. This double-blind, randomized, crossover, placebo-controlled study investigated whether an infusion of NXY-059 (15 mg/mL) during 12 hours affects the diuretic and saluretic effects of a 30-mg intravenous bolus dose of furosemide (10 mg/mL) administered after 6 hours' infusion, in 13 male and 11 female healthy subjects. The net increase in urine volume and sodium excretion in the interval of 6 to 12 hours was 4.15 L and 178 mmol/L, respectively, during NXY-059 treatment (P = .93) and 4.34 L and 190 mmol/L, respectively, during placebo treatment (P = .54). NXY-059 reduced the renal clearance of furosemide by 19% (P = .019), and furosemide reduced the renal clearance of NXY-059 by 8% (P = .005). NXY-059 was well tolerated.

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

Address for reprints: Stig Strid, PhD, AstraZeneca R&D, Södertälje, SE-151 85, Södertälje, Sweden; e-mail: stig.strid{at}astrazeneca.com.