Evaluating brain receptor occupancy and safety of ITI-1284 in healthy individuals

An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects

This study is testing how a new drug called ITI-1284 affects certain brain receptors in healthy people to see if it's safe and how it works.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Intra-Cellular Therapies, Inc. (Industry-sponsored)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06299410 on ClinicalTrials.gov

What this trial studies

This open-label, single-center study aims to assess the occupancy of ITI-1284 on dopamine D2 receptors, serotonin 2A receptors, and serotonin transporters in healthy subjects. The study is divided into three parts: Part A will focus on D2 receptor occupancy at two different doses, Part B will evaluate 5-HT2A receptor and SERT occupancy at one dose, and Part C will explore the time course of receptor occupancy at one dose level. Participants will be monitored for safety and pharmacokinetics throughout the study.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 50 with a BMI between 18 and 32 kg/m2.

Not a fit: Patients with significant health issues or a history of psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the pharmacological effects of ITI-1284, potentially leading to new treatments for conditions related to these receptors.

How similar studies have performed: While this study focuses on a specific compound, similar studies evaluating receptor occupancy have shown promise in understanding drug effects, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Healthy male and female subjects between 18 and 50 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 Criteria:

* 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 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.

Where this trial is running

New Haven, Connecticut

• Clinical Site 1 — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: ITI Clinical Trials

Conditions Healthy Volunteers