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

NCT ID: NCT06299410

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2025-09-30

Brief 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.

Detailed Description

This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at two dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C (optional) will evaluate the time course of receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A1: 10 mg ITI-1284

Radioligand: \[11C\]-raclopride

Group Type: EXPERIMENTAL

ITI-1284 10 mg

Intervention Type: DRUG

ITI-1284 tablet

Cohort A2: 20 mg ITI-1284

Radioligand: \[11C\]-raclopride

Group Type: EXPERIMENTAL

ITI-1284 20 mg

Intervention Type: DRUG

ITI-1284 tablet

Cohort B1: 20 mg ITI-1284

Radioligand: \[11C\]-MDL100907

Group Type: EXPERIMENTAL

ITI-1284 20 mg

Intervention Type: DRUG

ITI-1284 tablet

Cohort B2: 20 mg ITI-1284

Radioligand: \[11C\]-DASB

Group Type: EXPERIMENTAL

ITI-1284 20 mg

Intervention Type: DRUG

ITI-1284 tablet

Cohort C: 20 mg ITI-1284

Radioligand: \[11C\]-MDL100907 or \[11C\]-raclopride

Group Type: EXPERIMENTAL

ITI-1284 20 mg

Intervention Type: DRUG

ITI-1284 tablet

Interventions

ITI-1284 10 mg

ITI-1284 tablet

Intervention Type: DRUG

ITI-1284 20 mg

ITI-1284 tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Site 1

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

ITI Clinical Trials

Role: CONTACT

ITCIClinicalTrials@itci-inc.com

646 440-9333

Other Identifiers

ITI-1284-008

Identifier Type: -

Identifier Source: org_study_id