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

• Sponsor: Intra-Cellular Therapies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03489772
• Collaborator: Laureate Institute for Brain Research, Inc. (Other)
• Enrollment: 26
• Location: 1
• Arms: 3
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ITI-214; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jul 10, 2018
• Actual Primary Completion Date: Aug 5, 2019
• Actual Study Completion Date: Aug 5, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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

3. Number of subjects with reported or observed treatment-related adverse events [0-5 hours post-dose]

   Safety and tolerability

Other Outcome Measures

1. BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex [1-3 hours post-dose]

   Pharmacodynamics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laureate Institute for Brain Research, Inc.	Tulsa	Oklahoma	United States	74136

Sponsors and Collaborators

• Intra-Cellular Therapies, Inc.
• Laureate Institute for Brain Research, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Intra-Cellular Therapies, Inc.
• ClinicalTrials.gov Identifier: NCT03489772
• Other Study ID Numbers: ITI-214-106
• First Posted: Apr 5, 2018
• Last Update Posted: Nov 6, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 6, 2019