Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics

Background and Objective Schizophrenia and Alzheimer’s disease are characterised by abnormalities in glutamatergic pathways related to N-methyl-d-aspartate receptor hypofunction. Glycine is an N-methyl-d-aspartate receptor co-agonist; inhibition of glycine transporter 1 may improve N-methyl-d-aspartate receptor function. This phase I, randomised, two-part study evaluated the safety, tolerability and pharmacokinetic profile of BI 425809, a novel glycine transporter 1 inhibitor, in healthy male and female volunteers.