ITI-333 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinical Site 1, Saint Louis, MO
Healthy Subjects (HS)
ITI-333 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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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)

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)

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
Photo of Saint Louis 1Photo of Saint Louis 2Photo of Saint Louis 3
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

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About The Reviewer

Michael Gill preview

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.