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

Description

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.

Conditions

Healthy Volunteers

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

New Haven

Clinical Site 1, New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Intra-Cellular Therapies, Inc.,

Study Record Dates

2025-09