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Completed Phase 1 Interventional Accepts healthy volunteers

Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

ClinicalTrials.gov ID: NCT03489772

Public ClinicalTrials.gov record NCT03489772. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Placebo-Controlled, Double-Blind Study of Escalating Single Doses of ITI-214 in Healthy Volunteers to Determine Central Nervous System Engagement, Safety and Tolerability

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.

Study identification

NCT ID
NCT03489772
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Enrollment
26 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 9, 2018
Primary completion
Aug 4, 2019
Completion
Aug 4, 2019
Last update posted
Nov 5, 2019

2018 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Laureate Institute for Brain Research, Inc. Tulsa Oklahoma 74136

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03489772, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 5, 2019 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03489772 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →