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Completed

NCT Number: NCT05470101

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site 2, Creve Coeur, Missouri, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ITI-333

Drug

ITI-333 oral solution

Primary outcomes

  1. Pharmacodynamics: 5-HT2A receptor occupancy (RO) using [11C]-MDL100907

    Time frame: baseline 90-minute PET scan between Day -10 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose

  2. Pharmacokinetics: AUC0-t

    Time frame: predose and multiple timepoints up to 24 hours postdose

    Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333

  3. Pharmacokinetics: Cmax

    Time frame: predose and multiple timepoints up to 24 hours postdose

    Maximum observed plasma concentration

  4. Pharmacokinetics: Tmax

    Time frame: predose and multiple timepoints up to 24 hours postdose

    Time to reach maximum observed plasma concentration

Secondary outcomes

  1. Percentage of subjects with treatment-emergent adverse events

    Time frame: up to 30 days after last dose

  2. Change from baseline in systolic and diastolic blood pressure

    Time frame: Up to Day 7

  3. Change from baseline in ECG QT interval

    Time frame: Up to Day 7

  4. Change from baseline in aspartate aminotransferase

    Time frame: Up to Day 7

  5. Change from baseline in alanine aminotransferase

    Time frame: Up to Day 7

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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