NCT01940159

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856	SEP-36385625 as a single oral dose of 25, 50, 100, and 150 mcg
DRUG	Placebo	single oral dose placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-09-12
• Last updated: 2024-06-26

Locations

2 sites across 1 country: United States