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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT01940159

Public ClinicalTrials.gov record NCT01940159. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Single-Blind, Placebo-Controlled, Ascending Single Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia.

Study identification

NCT ID
NCT01940159
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
48 participants

Conditions and interventions

Conditions

Interventions

  • SEP-363856 Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2013
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014
Last update posted
Jun 25, 2024

2013 – 2014

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
California Clinical Trials Medical Group Glendale California 91206
Collaborative Neuroscience Network, LLC Long Beach California 90806

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01940159, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 25, 2024 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01940159 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →