Kanae Co., Ltd.

Primary efficacy objective To evaluate the efficacy of fixed-dose SEP-363856 compared with placebo in patients with acute schizophrenia by measuring the total score of the Positive and Negative Syndrome Scale (PANSS) Secondary efficacy objectives To evaluate the efficacy of fixed-dose SEP-363856 compared with placebo in patients with acute schizophrenia psychosis by measuring the Clinical Global Impression-Severity (CGI-S) score Other efficacy objectives To evaluate the long-term effectiveness of flexible-dose SEP-363856 in patients with acute schizophrenia by measuring the total score of PANSS and CGI-S score; UPSM factor scores and the total scores of the Brief Negative Symptom Scale and the Montgomery-Asberg Depression Rating Scale were used to evaluate the efficacy of fixed doses and the long-term effectiveness of flexible dose SEP-363856 in patients with acute schizophrenia. Safety objectives Incidence of overall AEs, serious AEs, and AEs leading to discontinuation Pharmacokinetic objectives Population pharmacokinetic (POPPK) analysis using plasma SEP-363856 concentrations. The relationship between PANSS total score and plasma SEP-363856 exposure was explored by POPPK/pharmacodynamic methods. The effect of CYP2D6 metabolizer status on SEP-363856 plasma exposure was explored. Patients who completed the 6-week double-blind period were eligible to enter the 12-week open-label period.

Primary objective: To evaluate the PK characteristics of SEP-363856 and its metabolites SEP-363854 and SEP-383103 in plasma after a single oral administration of SEP-363856 in healthy Chinese male adult subjects; to evaluate the PK characteristics of SEP-363856 and its metabolites SEP-363854 and SEP-383103 in plasma after multiple oral administrations of SEP-363856 in healthy Chinese male adult subjects. Secondary objective: To evaluate the relationship between dose and plasma concentration of SEP-363856 and its metabolites SEP-363854 and SEP-383103 after a single oral administration of SEP-363856 in healthy Chinese male adult subjects. To evaluate the PK characteristics of SEP-363856 and its metabolites SEP-363854 and SEP-383103 in urine after a single oral administration of SEP-363856 in healthy Chinese male adult subjects. To evaluate the relationship between the plasma concentrations of SEP-363856 and its metabolites SEP-363854 and SEP-383103 on the 1st and 7th days after multiple oral administration of SEP-363856 in healthy Chinese adult male subjects. Safety: To evaluate the safety of SEP-363856 after a single oral administration. To evaluate the safety of SEP-363856 after multiple oral administration. Others: To explore the effect of CYP2D6 metabolizer on the plasma concentration of SEP-363856. To evaluate the effect of SEP-363856 on exercise

The subjects are patients with chronic renal failure whose primary disease is primary glomerular disease or nephrosclerosis. - To study the superiority of TRK-100STP compared with placebo - To determine the clinically recommended dose of TRK-100STP (120μg/day or 240μg/day) - To evaluate the safety of TRK-100STP.