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

> **NCT01994473** · PHASE1 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 48 (actual)

## Conditions studied

- Schizophrenia

## Interventions

- **DRUG:** SEP-363856
- **DRUG:** Placebo
- **DRUG:** SEP-363856 Open Label

## Key facts

- **NCT ID:** NCT01994473
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-10
- **Primary completion:** 2014-12
- **Final completion:** 2014-12
- **Target enrollment:** 48 (ACTUAL)
- **Last updated:** 2024-06-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01994473

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01994473, "Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT01994473. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*