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

NCT06299410 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ITI-1284-008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• % Receptor occupancy

  Percent change of binding potential from baseline

  Day 1

Secondary Outcomes (7)

• Pharmacokinetics: AUC0-t

  Day 1

• Pharmacokinetics: Cmax

  Day 1

• Pharmacokinetics: Tmax

  Day 1

• Percentage of subjects with treatment-emergent adverse events

  Up to 30 days after the dose of study drug

• Change from baseline in ECG QT interval

  Day 3

Study Arms (5)

Cohort A1: 10 mg ITI-1284

EXPERIMENTAL

Radioligand: \[11C\]-raclopride

Drug: ITI-1284 10 mg

Cohort A2: 20 mg ITI-1284

EXPERIMENTAL

Radioligand: \[11C\]-raclopride

Drug: ITI-1284 20 mg

Cohort B1: 20 mg ITI-1284

EXPERIMENTAL

Radioligand: \[11C\]-MDL100907

Drug: ITI-1284 20 mg

Cohort B2: 20 mg ITI-1284

EXPERIMENTAL

Radioligand: \[11C\]-DASB

Drug: ITI-1284 20 mg

Cohort C: 20 mg ITI-1284

EXPERIMENTAL

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

Drug: ITI-1284 20 mg

Interventions

ITI-1284 10 mg DRUG

ITI-1284 tablet

Cohort A1: 10 mg ITI-1284

ITI-1284 20 mg DRUG

ITI-1284 tablet

Cohort A2: 20 mg ITI-1284; Cohort B1: 20 mg ITI-1284; Cohort B2: 20 mg ITI-1284; Cohort C: 20 mg ITI-1284

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (1)

Clinical Site 1

New Haven, Connecticut, 06520, United States

RECRUITING

Central Study Contacts

ITI Clinical Trials

CONTACT

646 440-9333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study includes up to 3 sequential parts (Parts A, B and C). Within Parts A and B, subjects will be assigned to 1 of 2 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan. In Part C (optional), subjects will receive a single dose of ITI-1284 and undergo up to 3 postdose PET/CT scans.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 11, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)