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

Intra-Cellular Therapies

Status and phase

Enrolling

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: ITI-1284 20 mg

Drug: ITI-1284 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06299410

ITI-1284-008

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.