RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-11

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06299410

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.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

ITI Clinical Trials

CONTACT

646 440-9333

ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site 1

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-11

Study Completion Date2025-09

Study Record Updates

Study Start Date2024-04-11

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteers