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

November 5, 2019 updated by: Intra-Cellular Therapies, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Laureate Institute for Brain Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female, 18 - 45 years
  • Fluent and literate in English and able to provide written informed consent
  • BMI between 18.5 and 38.0 kg/m2 and minimum body weight of 50 kg

Exclusion Criteria:

  • Recent exposure to any investigational product
  • Previous exposure to relevant fMRI task(s)
  • Considered medically unsuitable for participation
  • Has any contraindication for BOLD fMRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Single dose
Drug: Placebo
Oral
Experimental: 1 mg ITI-214
Single dose
Drug: ITI-214
Oral
Experimental: 10 mg ITI-214
Single dose
Drug: ITI-214
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task
Time Frame: 1-3 hours post-dose
Changes in brain activation
1-3 hours post-dose
BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task
Time Frame: 1-3 hours post-dose
Changes in brain activation
1-3 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD fMRI signals elicited by fear conditioning stimulus
Time Frame: 1-3 hours post-dose
Changes in brain activation in amygdala, prefrontal cortex, and/or insula cortex
1-3 hours post-dose
BOLD fMRI signals elicited by the Stop versus Go signal
Time Frame: 1-3 hours post-dose
Changes in brain activation in dorsolateral prefrontal cortex and/or anterior cingulate cortex
1-3 hours post-dose
Number of subjects with reported or observed treatment-related adverse events
Time Frame: 0-5 hours post-dose
Safety and tolerability
0-5 hours post-dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex
Time Frame: 1-3 hours post-dose
Pharmacodynamics
1-3 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Collaborators

Laureate Institute for Brain Research, Inc.

Investigators

  • Study Director: Robert Davis, PhD, Intra-Cellular Therapies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Actual)

August 5, 2019

Study Completion (Actual)

August 5, 2019

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ITI-214-106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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