Clinical trial NCT05470101: A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
Official title: An Open-label, Positron Emission Tomography (PET) Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After Single Oral Doses of ITI-333 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects. Subjects will have a baseline PET/CT scan and a postdose PET/CT scan using \[14C\]-MDL100907 to characterize 5-HT2A receptor occupancy


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between 18 and 45 years old (inclusive);
* BMI inclusive of 18.0-32.0 kg/m2 at screening and a minimum weight of 50 kg;
* Willing to be confined to the clinical research unit for the duration of the inpatient period of the study;

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 (including history of gastric bypass), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \< 96% and respiratory rate \< 12 breaths per min;
* 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).

Primary outcomes:
measure: Pharmacodynamics: Receptor occupancy (RO)
timeFrame: baseline 90-minute PET scan between Day -5 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose
measure: Pharmacokinetics: AUC0-t
timeFrame: predose and multiple timepoints up to 24 hours postdose
Secondary outcomes:
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: up to 30 days after last dose
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Up to Day 7
measure: Change from baseline in ECG QT interval
timeFrame: Up to Day 7
measure: Change from baseline in aspartate aminotransferase
timeFrame: Up to Day 7
measure: Change from baseline in alanine aminotransferase
timeFrame: Up to Day 7
Other outcomes:
Locations:
city: Creve Coeur
country: United States
facility: Clinical Site 2
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Site 1
state: Missouri
Study officials:
References: