Actively Recruiting
Study to Evaluate Brain Receptor Binding, Safety, and Pharmacokinetics After a Single Sublingual Dose of ITI-1284 in Healthy Adults Using PET Imaging
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
Researchers are conducting an open-label, single-center Phase 1 study to evaluate how the investigational drug ITI-1284 binds to specific brain receptors in healthy adults aged 18 to 50. The study aims to assess ITI-1284's occupancy of dopamine D2, serotonin 2A (5-HT2A), and serotonin transporter (SERT) receptors, while also monitoring safety and pharmacokinetics after a single dose. The study has up to three sequential parts. Part A will test two dose levels of ITI-1284 tablets (10 mg and 20 mg) to measure dopamine D2 receptor occupancy. Part B will assess 5-HT2A receptor and SERT occupancy at one dose level. An optional Part C will evaluate how receptor occupancy changes over time at one dose level. All doses are administered sublingually. Participants will stay in the hospital research unit during the inpatient period for monitoring. Researchers will use positron emission tomography (PET) scans to measure receptor occupancy and collect data on safety, tolerability, and pharmacokinetics. The primary outcome is the percentage of receptor occupancy on Day 1 after dosing. The study includes detailed vital sign assessments and safety evaluations throughout the participation period.
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
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Trial Site Locations
Total: 1 location
1
Clinical Site 1
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
I
ITI Clinical Trials
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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