Francis M Dijkstra, Rob G J A Zuiker, Jules A A C Heuberger, Kawita M S Kanhai, Marieke De Kam, Thierry Duvauchelle, Jeanne-Marie Lecomte, Olivier Labeeuw, Laurent Landais, Xavier Ligneau, Philippe Robert, Marc Capet, Jean-Charles Schwartz, Joop M A van Gerven
AIMS: To characterise the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of oxathridine, a first-in-class histamine-3 receptor partial agonist, in healthy male volunteers. METHODS: A randomised, double-blind, placebo-controlled study including the NeuroCart, consisting of a battery of drug sensitive neurophysiological tests, was performed. Oxathridine was administered orally as an aqueous solution. After dosing, safety and NeuroCart tests (adaptive tracking [AT], body sway [BS], saccadic peak velocity [SPV], smooth pursuit [SP] eye movements, VAS according to Bond and Lader, VAS according to Bowdle [VAS B&L, Bowdle], pharmaco-electroencephalogram [pEEG], Sustained Attention to Response Task [SART]) were performed at set times...
September 19, 2023: British Journal of Clinical Pharmacology