CompletedNCT03489772Updated Nov 6, 2019

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

A Phase 1 interventional study of ITI-214 and Placebo in Healthy Volunteers, sponsored by Intra-Cellular Therapies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-06.

Sponsored by Intra-Cellular Therapies, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 26
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Conditions studied

Healthy Volunteers

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: 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

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 26 participants (actual)

Study arms

Experimental
1 mg ITI-214
Single dose
Drug: ITI-214
Experimental
10 mg ITI-214
Single dose
Drug: ITI-214
Placebo comparator
Placebo
Single dose
Drug: Placebo

Interventions

DrugITI-214
Oral
DrugPlacebo
Oral

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Study locations

1 site

Laureate Institute for Brain Research, Inc.
Tulsa, Oklahoma 74136, United States

References and documents

Publications

Khalsa SS, Victor TA, Kuplicki R, Yeh HW, Vanover KE, Paulus MP, Davis RE. Single doses of a highly selective inhibitor of phosphodiesterase 1 (lenrispodun) in healthy volunteers: a randomized pharmaco-fMRI clinical trial. Neuropsychopharmacology. 2022 Sep;47(10):1844-1853. doi: 10.1038/s41386-022-01331-3. Epub 2022 Apr 29. PubMed 35488084 ↗

Registry details

Key details

Study ID: NCT03489772
Lead sponsor: Intra-Cellular Therapies, Inc.
Collaborators: Laureate Institute for Brain Research, Inc.
Responsible party: Sponsor
First posted: Apr 5, 2018
Start date: Jul 10, 2018
Primary completion: Aug 5, 2019
Completion: Aug 5, 2019
Last update: Nov 6, 2019

Study contacts

Robert Davis, PhD

study director · Intra-Cellular Therapies, Inc.

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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