Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 31, 2020

Primary Completion Date

August 7, 2020

Study Completion Date

August 7, 2020

Conditions
Schizophrenia
Interventions
DRUG

SEP-363856

Dosing of the SEP-363856 group in Cohort 1 will be initiated at 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days. The SEP-363856 group in Cohort 2 will be dosed at 25 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days.

DRUG

Placebo

Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.

Trial Locations (8)

836-0004

Shiranui Hospital, Omuta-shi

570-0005

Nishiurakai Keihan Hospital, Osaka-Fu

386-0401

Mental Support SOYOKAZE Hospital, Ueda-shi

904-1201

NHO Ryukyu Hospital, Kunigami-gun

842-0104

NHO Hizen Psychiatric Center, Kanzaki

847-0031

Rainbow & Sea Hospital, Karatsu-shi

841-0081

Inuo Mental Care Hospital, Tosu

819-0037

Kuramitsu Hospital, Fukuoka

All Listed Sponsors
lead

Sumitomo Pharma Co., Ltd.

INDUSTRY

NCT04325737 - Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia | Biotech Hunter | Biotech Hunter