Study design
PD, schizophrenia
This was a randomized, double-blind, placebo-controlled, two-sequence, two-period, crossover, phase 2a study assessing pharmacodynamic (PD) effects, safety, tolerability, and pharmacokinetics (PK) of multiple daily oral doses of luvadaxistat in adult patients with schizophrenia. The study was conducted in accordance with regulations relating to Good Clinical Practice, approved by the University of Maryland Baltimore Institutional Review Board, and registered at Patients were randomized to receive 8 days of luvadaxistat (either 50 mg or 500 mg once daily) followed by 8 days of placebo after a 2- to 3-week washout period, or 8 days of placebo followed by luvadaxistat 50 mg or 500 mg once daily after a similar washout (Fig. 