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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ITI-214; Drug: Placebo

• Registration Number: NCT03489772
• Lead Sponsor: Intra-Cellular Therapies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-05
• Study Start: 2018-07-10
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10 mg ITI-214	ITI-214	Single dose
Placebo	Placebo	Single dose
1 mg ITI-214	ITI-214	Single dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Number of subjects with reported or observed treatment-related adverse events	0-5 hours post-dose	Safety and tolerability

Trial Locations

Locations (1)

Laureate Institute for Brain Research, Inc.; 🇺🇸 Tulsa, Oklahoma, United States