The safety, tolerability and pharmacokinetics of BI 409306, a novel and potent PDE9 inhibitor: Overview of three Phase I randomised trials in healthy volunteers

Safety, tolerability and pharmacokinetics of BI 409306, a potent and selective phosphodiesterase 9A inhibitor, were assessed in healthy subjects in three Phase I, within-dose group, double-blind trials. Trial 1 randomised young and elderly subjects to receive BI 409306 25, 50, 100  mg, placebo once daily (OD) or BI 409306 50 mg twice daily (young) for 14 days. Trial 2 randomised young poor metabolisers (PM) of cytochrome P450 isoform 2C19 (CYP2C19) and elderly subjects to receive BI 409306 25, 50 mg or placebo OD for 14 days.

Source: European Neuropsychopharmacology - March 19, 2018 Category: Psychiatry & Psychology Authors: Viktoria Moschetti, Maria Kim, Michael Sand, Glen Wunderlich, Grit Andersen, Ulrich Feifel, In-Jin Jang, Wolfgang Timmer, Holger Rosenbrock, Katja Boland Source Type: research