PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ITI-1284 10 mg, ITI-1284 20 mg.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects
Overview
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.
Detailed description
This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at three dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C will evaluate the late postdose receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.
Interventions
- Drug ITI-1284 10 mg
ITI-1284 tablet - Drug ITI-1284 20 mg
ITI-1284 tablet
Primary outcome measures
- % Receptor occupancy [Time frame: Day 1]
Secondary outcome measures (7)
- Pharmacokinetics: AUC0-t [Time frame: Day 1]
- Pharmacokinetics: Cmax [Time frame: Day 1]
- Pharmacokinetics: Tmax [Time frame: Day 1]
- Percentage of subjects with treatment-emergent adverse events [Time frame: Up to 30 days after the dose of study drug]
- Change from baseline in ECG QT interval [Time frame: Day 3]
- Change from baseline in aspartate aminotransferase [Time frame: Day 3]
- Change from baseline in alanine aminotransferase [Time frame: Day 3]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale University School Of Medicine — New Haven
Identifiers
NCT: NCT06299410 · ITI-1284-008 · ITI-1284-008