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

Recruiting at 1 trial location

Overseen By ITI Clinical Trials

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Intra-Cellular Therapies, Inc.

Disqualifiers: Cardiac, Hepatic, Renal, Neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 1 day

12 Participants Needed

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

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

Group I: Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3 Experimental Treatment 1 Intervention

Group II: Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2 Experimental Treatment 1 Intervention

Group III: Cohort A2: ITI-333 dose to be determined based on Cohort A1 Experimental Treatment 1 Intervention

Group IV: Cohort A1: ITI-333 2.25 mg Experimental Treatment 1 Intervention

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+