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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489772
• Other study ID #: ITI-214-106
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2018
• Est. completion date: August 5, 2019

Study information

• Verified date: November 2019
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ITI-214
Oral
• Placebo
Oral

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research, Inc.	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.	Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex	Pharmacodynamics	1-3 hours post-dose
Primary	BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task	Changes in brain activation	1-3 hours post-dose
Primary	BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task	Changes in brain activation	1-3 hours post-dose
Secondary	BOLD fMRI signals elicited by fear conditioning stimulus	Changes in brain activation in amygdala, prefrontal cortex, and/or insula cortex	1-3 hours post-dose
Secondary	BOLD fMRI signals elicited by the Stop versus Go signal	Changes in brain activation in dorsolateral prefrontal cortex and/or anterior cingulate cortex	1-3 hours post-dose
Secondary	Number of subjects with reported or observed treatment-related adverse events	Safety and tolerability	0-5 hours post-dose