Clinical trial NCT06299410: PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study includes up to 3 sequential parts (Parts A, B and C). Within Parts A and B, subjects will be assigned to 1 of 2 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan. In Part C (optional), subjects will receive a single dose of ITI-1284 and undergo up to 3 postdose PET/CT scans.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at two dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C (optional) will evaluate the time course of receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between 18 and 50 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 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.

Primary outcomes:
measure: % Receptor occupancy
timeFrame: Day 1
Secondary outcomes:
measure: Pharmacokinetics: AUC0-t
timeFrame: Day 1
measure: Pharmacokinetics: Cmax
timeFrame: Day 1
measure: Pharmacokinetics: Tmax
timeFrame: Day 1
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: Up to 30 days after the dose of study drug
measure: Change from baseline in ECG QT interval
timeFrame: Day 3
measure: Change from baseline in aspartate aminotransferase
timeFrame: Day 3
measure: Change from baseline in alanine aminotransferase
timeFrame: Day 3
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Clinical Site 1
state: Connecticut
Study officials:
References: