English to Russian Medical Medical: Pharmaceuticals

Luvadaxistat demonstrated a favorable safety profile in both Phase 2 studies. Furthermore, the proposed doses are also supported by Phase 1 single-rising dose (SRD)/multiple rising dose (MRD) PK data (Studies TAK-831-1001 and TAK-831-1005), food-effect PK data (Study TAK 831-1004), brain target occupancy (PET) data (Study TAK-831-1003), CSF D serine data (Study TAK-831-1005), and safety data from all clinical studies after oral administration of luvadaxistat in healthy subjects. The planned dose regimens are expected to deliver mean exposures within the range previously studied in Studies TAK-831-1001 and TAK 831-1005 that were found to be well tolerated in healthy subjects.