NCT05470101

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2022

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

July 26, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

July 20, 2022

Last Update Submit

September 3, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

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

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

  • Pharmacokinetics: AUC0-t

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

    predose and multiple timepoints up to 24 hours postdose

  • Pharmacokinetics: Cmax

    Maximum observed plasma concentration

    predose and multiple timepoints up to 24 hours postdose

  • Pharmacokinetics: Tmax

    Time to reach maximum observed plasma concentration

    predose and multiple timepoints up to 24 hours postdose

Secondary Outcomes (5)

  • Percentage of subjects with treatment-emergent adverse events

    up to 30 days after last dose

  • Change from baseline in systolic and diastolic blood pressure

    Up to Day 7

  • Change from baseline in ECG QT interval

    Up to Day 7

  • Change from baseline in aspartate aminotransferase

    Up to Day 7

  • Change from baseline in alanine aminotransferase

    Up to Day 7

Study Arms (4)

Cohort A1: ITI-333 2.25 mg

EXPERIMENTAL
Drug: ITI-333

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

EXPERIMENTAL
Drug: ITI-333

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

EXPERIMENTAL
Drug: ITI-333

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

EXPERIMENTAL
Drug: ITI-333

Interventions

ITI-333DRUG

ITI-333 oral solution

Cohort A1: ITI-333 2.25 mgCohort A2: ITI-333 dose to be determined based on Cohort A1Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Site 2

Creve Coeur, Missouri, 63141, United States

Location

Clinical Site 1

St Louis, Missouri, 63110, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 22, 2022

Study Start

July 26, 2022

Primary Completion

May 3, 2023

Study Completion

May 3, 2023

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)