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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299410
• Other study ID #: ITI-1284-008
• Status: Recruiting
• Phase: Phase 1
• Start date: April 11, 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Intra-Cellular Therapies, Inc.
• Contact: ITI Clinical Trials
• Phone: 646 440-9333
• Email: ITCIClinicalTrials[@]itci-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ITI-1284 10 mg
ITI-1284 tablet
• ITI-1284 20 mg
ITI-1284 tablet

Locations

Country	Name	City	State
United States	Clinical Site 1	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Receptor occupancy	Percent change of binding potential from baseline	Day 1
Secondary	Pharmacokinetics: AUC0-t	Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration	Predose and multiple timepoints up to 24 hours postdose on Day 1
Secondary	Pharmacokinetics: Cmax	Maximum plasma concentration	Predose and multiple timepoints up to 24 hours postdose on Day 1
Secondary	Pharmacokinetics: Tmax	Time of maximum plasma concentration	Predose and multiple timepoints up to 24 hours postdose on Day 1
Secondary	Percentage of subjects with treatment-emergent adverse events		Up to 30 days after the dose of study drug
Secondary	Change from baseline in ECG QT interval		Up to Day 3
Secondary	Change from baseline in aspartate aminotransferase		Up to Day 3
Secondary	Change from baseline in alanine aminotransferase		Up to Day 3