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

NCT01940159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-06-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SEP-363856

SEP-36385625 as a single oral dose of 25, 50, 100, and 150 mcg

DRUG

Placebo

single oral dose placebo

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940159 on ClinicalTrials.gov