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drugset / Trial / NCT01940159

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

NCT01940159 ↗

Phase 1 Completed 48 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
RandomizedSingle-groupSingle-blindTreatment

Summary

This is a single-center, randomized, single-blind, placebo-controlled, ascending single oral dose study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.

Timeline

Start
2013-08
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ulotaront Small molecule 25 mg Oral
Comparator Ulotaront Small molecule 50 mg Oral
Comparator Ulotaront Small molecule 100 mg Oral
Comparator Ulotaront Small molecule 150 mg Oral

Indications

schizophrenia