A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

Intra-Cellular Therapies

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ITI-333

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05470101

ITI-333-003

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Cohort A1: ITI-333 2.25 mg

Experimental group

Treatment:

Drug: ITI-333

Cohort A2: ITI-333 dose to be determined based on Cohort A1

Experimental group

Treatment:

Drug: ITI-333

Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2

Experimental group

Treatment:

Drug: ITI-333

Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3

Experimental group

Treatment:

Drug: ITI-333