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Recruiting NCT06299410

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

Conditions: Healthy Volunteers

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 42
Sponsor: Intra-Cellular Therapies, Inc.

Location: Yale University School Of Medicine New Haven Connecticut

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.

Eligibility Criteria

Inclusion Criteria: * 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. 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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06299410). StuddyBuddy aggregates publicly available trial information.