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

Sponsor

Intra-Cellular Therapies, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05470101

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects. Subjects will have a baseline PET/CT scan and a postdose PET/CT scan using [14C]-MDL100907 to characterize 5-HT2A receptor occupancy

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ITI-333	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-label, Positron Emission Tomography (PET) Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After Single Oral Doses of ITI-333 in Healthy Subjects

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A1: ITI-333 2.25 mg	Drug: ITI-333 ITI-333 oral solution
Experimental: Cohort A2: ITI-333 dose to be determined based on Cohort A1	Drug: ITI-333 ITI-333 oral solution
Experimental: Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2	Drug: ITI-333 ITI-333 oral solution
Experimental: Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3	Drug: ITI-333 ITI-333 oral solution

Outcome Measures

Primary Outcome Measures

Pharmacodynamics: Receptor occupancy (RO) [baseline 90-minute PET scan between Day -5 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose]
Pharmacokinetics: AUC0-t [predose and multiple timepoints up to 24 hours postdose]
Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333 and its metabolites

Secondary Outcome Measures

Percentage of subjects with treatment-emergent adverse events [up to 30 days after last dose]
Change from baseline in systolic and diastolic blood pressure [Up to Day 7]
Change from baseline in ECG QT interval [Up to Day 7]
Change from baseline in aspartate aminotransferase [Up to Day 7]
Change from baseline in alanine aminotransferase [Up to Day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and female subjects between 18 and 45 years old (inclusive);
BMI inclusive of 18.0-32.0 kg/m2 at screening and a minimum weight of 50 kg;
Willing to be confined to the clinical research unit for the duration of the inpatient period of the study;

Exclusion Criteria:

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;
History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Site 2	Creve Coeur	Missouri	United States	63141
2	Clinical Site 1	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Intra-Cellular Therapies, Inc.
National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Intra-Cellular Therapies, Inc.

ClinicalTrials.gov Identifier:

NCT05470101

Other Study ID Numbers:

ITI-333-003

First Posted:

Jul 22, 2022

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 22, 2022