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Completed

NCT Number: NCT03489772

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Laureate Institute for Brain Research, Inc.

Tulsa, Oklahoma, 74136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ITI-214

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

  1. 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

  2. BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task

    Time frame: 1-3 hours post-dose

    Changes in brain activation

Secondary outcomes

  1. 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

  2. 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

  3. Number of subjects with reported or observed treatment-related adverse events

    Time frame: 0-5 hours post-dose

    Safety and tolerability

Other outcomes

  1. BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex

    Time frame: 1-3 hours post-dose

    Pharmacodynamics

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Collaborators

  • Laureate Institute for Brain Research, Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2018
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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