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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 predose and multiple timepoints up to 24 and 72 hours postdose on days 1 and 14, respectively
Awards & highlights
Study Summary
This trial will test a new drug on 8 healthy people to see if it's safe & effective. 6 will get the drug, 2 will get a placebo.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose and multiple timepoints up to 24 and 72 hours postdose on days 1 and 14, respectively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and multiple timepoints up to 24 and 72 hours postdose on days 1 and 14, respectively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in ECG QT interval
Change from baseline in SpO2
Change from baseline in alanine aminotransferase
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: 6 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions
Group II: Cohort 3: 3 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions
Group III: Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions
Group IV: Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 daysExperimental Treatment2 Interventions
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?
Intra-Cellular Therapies, Inc.Lead Sponsor
30 Previous Clinical Trials
7,499 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,488 Previous Clinical Trials
2,622,620 Total Patients Enrolled
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