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A PET Study Following a Single Oral Dose of ITI-333 in 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 predose and multiple timepoints up to 24 hours postdose
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, ITI-333, on healthy men and women to see how it affects mood and perception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and multiple timepoints up to 24 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and multiple timepoints up to 24 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetics: AUC0-t

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

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
2,594 Previous Clinical Trials
3,328,712 Total Patients Enrolled
Intra-Cellular Therapies, Inc.Lead Sponsor
40 Previous Clinical Trials
10,656 Total Patients Enrolled
~7 spots leftby Dec 2025
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