Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT01940159
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.
Study:
NCT01940159
Study Brief:
Protocol Section:
NCT01940159