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

Schizophrenia Clinical Trial

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.

Clinical Trial 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.

Clinical Trial Description

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

For each of the dose-escalation cohorts, 12 subjects (9 active subjects and 3 placebo subjects) will receive a single oral dose. An attempt will be made to have at least one-third of subjects in each cohort be female.

Each cohort will be comprised of 12 subjects (9 active, 3 placebo). Within each cohort, subjects will be randomized to receive either SEP-363856 (active) or matched placebo in a 3:1 ratio.

The planned dose levels that will be evaluated are:

- Cohort 1: A single oral 25 mg dose of SEP-363856 or matched placebo.

- Cohort 2: A single oral 50 mg dose of SEP-363856 or matched placebo.

- Cohort 3: A single oral 100 mg dose of SEP-363856 or matched placebo.

- Cohort 4: A single oral 150 mg dose of SEP-363856 or matched placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01940159
Study type Interventional
Source Sunovion
Contact
Status Completed
Phase Phase 1
Start date August 2013
Completion date March 2014
View Details
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