trial

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

NCTId NCT01994473
as of 2026-07-01
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at a glance
Phase 1 · Completed
Enrollment 48 (actual)
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion 2014-12
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 1
Status
Completed
Enrollment
48 (actual)
Study type
Interventional
Allocation
Randomized
Model
Single Group
Masking
Single
Start
2013-10
Primary completion
2014-12
Eligibility
ALL · 18 Years · 55 Years

Interventions & indications

Drugs
Ulotaront

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

Sites

2 total
Glendale, United StatesLong Beach, United States

Facts & assertions

4 sourced
Enrollment
48
Phase
PHASE1
Primary Completion Date
2014-12
Status
COMPLETED
relationships
The graph out of here
drug
Ulotaront
drug
lead_sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
company
indication
Schizophrenia
indication
Schizophrenia
indication