13
Participants
Start Date
March 31, 2020
Primary Completion Date
August 7, 2020
Study Completion Date
August 7, 2020
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.
Placebo
Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
Shiranui Hospital, Omuta-shi
Nishiurakai Keihan Hospital, Osaka-Fu
Mental Support SOYOKAZE Hospital, Ueda-shi
NHO Ryukyu Hospital, Kunigami-gun
NHO Hizen Psychiatric Center, Kanzaki
Rainbow & Sea Hospital, Karatsu-shi
Inuo Mental Care Hospital, Tosu
Kuramitsu Hospital, Fukuoka
Sumitomo Pharma Co., Ltd.
INDUSTRY