ITI-333 for Healthy Subjects (HS)

Phase-Based Progress Estimates

Effectiveness

Safety

Clinical Site 1, Saint Louis, MO

Healthy Subjects (HS)

ITI-333 - Drug

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Eligibility

18 - 65

All Sexes

What conditions do you have?

Select

Eligibility

18 - 65

All Sexes

What conditions do you have?

Select

Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

[11C]MeDAS

NOV-001

Medical device validation

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: baseline 90-minute PET scan between Day -5 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose

Up to Day 7

Change from baseline in ECG QT interval

Change from baseline in alanine aminotransferase

Change from baseline in aspartate aminotransferase

Change from baseline in systolic and diastolic blood pressure

Hour 1

Pharmacodynamics: Receptor occupancy (RO)

Hour 24

Pharmacokinetics: AUC0-t

Day 30

Percentage of subjects with treatment-emergent adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

[11C]MeDAS

NOV-001

Medical device validation

Trial Design

4 Treatment Groups

Cohort A1: ITI-333 2.25 mg

1 of 4

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

1 of 4

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

1 of 4

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

1 of 4

Experimental Treatment

24 Total Participants · 4 Treatment Groups

Primary Treatment: ITI-333 · No Placebo Group · Phase 1

Cohort A1: ITI-333 2.25 mg

Drug

Experimental Group · 1 Intervention: ITI-333 · Intervention Types: Drug

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

Drug

Experimental Group · 1 Intervention: ITI-333 · Intervention Types: Drug

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

Drug

Experimental Group · 1 Intervention: ITI-333 · Intervention Types: Drug

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

Drug

Experimental Group · 1 Intervention: ITI-333 · Intervention Types: Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ITI-333

2021

Completed Phase 1

~50

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: baseline 90-minute pet scan between day -5 and day -1, and a 90-minute pet scan starting at approximately 1 hour postdose

Closest Location: Clinical Site 1 · Saint Louis, MO

2011First Recorded Clinical Trial

1 TrialsResearching Healthy Subjects (HS)

7 CompletedClinical Trials

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor

23 Previous Clinical Trials

5,863 Total Patients Enrolled

2 Trials studying Healthy Subjects (HS)

74 Patients Enrolled for Healthy Subjects (HS)

National Institute on Drug Abuse (NIDA)NIH

2,203 Previous Clinical Trials

5,610,455 Total Patients Enrolled

31 Trials studying Healthy Subjects (HS)

4,369 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References