PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
Recruiting now · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT06299410
- Run by
- Intra-Cellular Therapies, Inc.
- People needed
- 42
- Starts
- 2024-04-11
- Expected to finish
- 2026-08-19
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female subjects between 18 and 55 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 supine 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.
Where it is running
- Yale University School Of Medicine — New Haven, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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