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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03489772

Enrollment

Registered

2018-04-05

Start date

2018-07-10

Completion date

2019-08-05

Last updated

2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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.

Interventions

DRUGITI-214

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026