Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-03-02 @ 12:02 AM
Study NCT ID:
NCT01940159
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2013-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: