Actively Recruiting
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
Led by Intra-Cellular Therapies, Inc. · Updated on 2025-01-28
30
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.
CONDITIONS
Official Title
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18 to 50 years (inclusive)
- Body mass index (BMI) between 18 and 32 kg/m2 at screening
- Minimum weight of 50 kg
- Willing to remain in the hospital research unit during the inpatient period
You will not qualify if you...
- Clinically significant abnormality within 2 years before screening that may pose risk or affect study outcomes, including cardiac, liver, kidney, neurological, gastrointestinal, lung, endocrine, blood, immune diseases, or history of cancer
- Abnormal vital signs at screening: supine systolic blood pressure > 140 mmHg or < 90 mmHg, diastolic blood pressure > 90 mmHg or < 50 mmHg, pulse rate > 100 bpm or < 45 bpm
- History of psychiatric conditions that may impact study participation
- Any condition preventing MRI or PET/CT scans (e.g., metal implants, claustrophobia, inability to fit in scanners)
- Contraindications found from previous MRI or study MRI before baseline PET/CT scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Site 1
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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