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PET Study of ITI-1284 in Healthy Volunteers

This study is looking for healthy volunteers aged 18 to 55 to test a drug called ITI-1284. The main goal is to see how much ITI-1284 attaches to certain brain receptors (dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT)) after one day. Researchers will also check how safe ITI-1284 is and how your body processes it. You can join if you are healthy, have a BMI between 18 and 32, weigh at least 50 kg, and are willing to stay in the hospital for the study period. The study's current status is unclear, and it plans to enroll 42 people.

Study design
This is an open-label study, meaning you and the researchers will know which dose of ITI-1284 you receive. It will involve up to 42 healthy volunteers and will be conducted at a single location.
What's involved
You will need to stay in the hospital research unit for the entire inpatient period. The study will involve taking ITI-1284 tablets at different doses.
Compensation
Not stated in the trial record.
Follow-up
The main measurement of receptor occupancy is taken on Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06299410

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

Completed
PHASE1Ages 18–55InterventionalTreatment
Intra-Cellular Therapies, Inc.
~58 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:ITI-1284 10 mgITI-1284 20 mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
% Receptor occupancy
Measured over Day 1

Conditions

Healthy Volunteers

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Healthy Volunteers

NCT06299410

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale University School Of Medicine

    New Haven, Connecticutno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Intra-Cellular Therapies, Inc. Clinical Trial · STUDY_DIRECTOR · Intra-Cellular Therapies, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Healthy male and female subjects between 18 and 55 years old (inclusive);
BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
Willingness to remain in the hospital research unit for the duration of the inpatient period.

Exclusion

Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
Clinically significant abnormal findings in vital sign assessments, supine SBP \> 140 mmHg or \< 90 mmHg, or supine DBP \>90 mmHg or \< 50 mmHg or supine pulse rate \> 100 bpm or \< 45 bpm at Screening;
History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners);
Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET/CT scan.

What this trial measures

  • % Receptor occupancyDay 1

    Percent change of binding potential from baseline