12 Participants Needed

A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

Recruiting at 1 trial location
IC
Overseen ByITI Clinical Trials
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Intra-Cellular Therapies, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy subjects, it is likely that participants should not be on any regular medications.

What is the purpose of this trial?

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

Eligibility Criteria

Inclusion Criteria

Willing to be confined to the clinical research unit for the duration of the inpatient period of the study
BMI inclusive of 18.0-32.0 kg/m2 at screening and a minimum weight of 50 kg

Exclusion Criteria

You have a mental health condition that might make it difficult for you to take part in the study, according to the doctor's opinion.
Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (including history of gastric bypass), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy
Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) < 96% and respiratory rate < 12 breaths per min
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo a baseline PET/CT scan to assess initial brain receptor status

1 day
1 visit (in-person)

Treatment

Participants receive a single oral dose of ITI-333 followed by a postdose PET/CT scan to evaluate receptor occupancy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics up to 24 hours postdose

1 day
Multiple timepoints up to 24 hours postdose

Treatment Details

Interventions

  • ITI-333
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials
42
Recruited
10,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security