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. (part of Johnson & Johnson) · Phase 1, Interventional, and Basic science
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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.
Intra-Cellular Therapies, Inc. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose
Drug: ITI-214
Single dose
Drug: ITI-214
Single dose
Drug: Placebo
Oral
Oral
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
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
BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex
Pharmacodynamics
Time frame: 1-3 hours post-dose
Ran from Jul 2018 to primary completion in Aug 2019, 12 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ITI-214
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