trial

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).

NCTId NCT03370640
as of 2026-07-01
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at a glance
Phase 1 · Completed
Enrollment 24 (actual)
Sponsored by Sumitomo Pharmaceuticals America
Primary completion 2018-09-20
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 1
Status
Completed
Enrollment
24 (actual)
Study type
Interventional
Allocation
Non Randomized
Model
Sequential
Masking
None
Start
2017-11-29
Primary completion
2018-09-20
Eligibility
ALL · 18 Years · 55 Years

Interventions & indications

Drugs
Ulotaront

Sponsors

Sumitomo Pharmaceuticals AmericaLead Sponsor

Sites

8 total
Kōnan, JapanAtsugi, JapanUeda, JapanSakai, JapanSetagaya-Ku, JapanItabashi-Ku, JapanKumamoto, JapanSaga, Japan

Facts & assertions

4 sourced
Enrollment
24
Phase
PHASE1
Primary Completion Date
2018-09-20
Status
COMPLETED
relationships
The graph out of here
drug
Ulotaront
drug
lead_sponsor
Sumitomo Pharmaceuticals America
company
indication
Schizophrenia
indication
Schizophrenia
indication