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ITI-333 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 90-minute pet scan between day -5 and day -1, and a 90-minute pet scan starting at approximately 1 hour postdose
Awards & highlights

Study Summary

This trial will study the effects of ITI-333, a possible new drug, on healthy male and female subjects. There will be up to 4 doses studied, and each group of 6 subjects will have PET/CT scans before and after taking the drug to measure its effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 90-minute pet scan between day -5 and day -1, and a 90-minute pet scan starting at approximately 1 hour postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 90-minute pet scan between day -5 and day -1, and a 90-minute pet scan starting at approximately 1 hour postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacodynamics: Receptor occupancy (RO)
Pharmacokinetics: AUC0-t
Secondary outcome measures
Electrocardiogram
Change from baseline in alanine aminotransferase
Aspartate Transaminase
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3Experimental Treatment1 Intervention
Group II: Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2Experimental Treatment1 Intervention
Group III: Cohort A2: ITI-333 dose to be determined based on Cohort A1Experimental Treatment1 Intervention
Group IV: Cohort A1: ITI-333 2.25 mgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ITI-333
2020
Completed Phase 1
~50

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,569 Total Patients Enrolled
Intra-Cellular Therapies, Inc.Lead Sponsor
29 Previous Clinical Trials
7,123 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
2022. "A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470101.
~9 spots leftby Apr 2025
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