RecruitingPhase 1NCT06299410

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

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


Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

30 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study uses PET brain scans to measure how much of a new experimental drug, ITI-1284, reaches and attaches to specific receptors in the brain in healthy volunteers. This helps determine the right dose for future studies. **You may be eligible if...** - You are a healthy male or female between 18 and 50 years old - Your BMI is between 18–32 kg/m² and you weigh at least 50 kg - You are willing to stay in the hospital research unit for the inpatient period of the study **You may NOT be eligible if...** - You have a significant medical condition (heart, liver, kidney, neurological, or immune disease) within the past 2 years - Your blood pressure, heart rate, or vital signs are outside of normal ranges at screening - You have a psychiatric history that could affect study participation - You have any contraindication to MRI or PET/CT scans (such as metal implants, claustrophobia, or inability to fit in the scanner) - You have abnormal results on MRI done before the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGITI-1284 10 mg

ITI-1284 tablet

DRUGITI-1284 20 mg

ITI-1284 tablet


Locations(1)

Clinical Site 1

New Haven, Connecticut, United States

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NCT06299410


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