Healthy VolunteersPhase 1NCT05470101
A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
A Phase 1 study testing ITI-333 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ITI-333
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2022to 3 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Site 2
Creve Coeur, Missouri, 63141
Clinical Site 1
St Louis, Missouri, 63110
About this study
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
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
- Conditions
- Healthy Volunteers
- Being tested
- ITI-333
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-333Drug
ITI-333 oral solution
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: ITI-333 2.25 mg | Experimental | Not described Receives: Drug: ITI-333 |
| Cohort A2: ITI-333 dose to be determined based on Cohort A1 | Experimental | Not described Receives: Drug: ITI-333 |
| Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2 | Experimental | Not described Receives: Drug: ITI-333 |
| Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3 | Experimental | Not described Receives: Drug: ITI-333 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: 5-HT2A receptor occupancy (RO) using [11C]-MDL100907
Measured: baseline 90-minute PET scan between Day -10 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose
Pharmacokinetics: AUC0-t
Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333
Measured: predose and multiple timepoints up to 24 hours postdose
Pharmacokinetics: Cmax
Maximum observed plasma concentration
Measured: predose and multiple timepoints up to 24 hours postdose
Pharmacokinetics: Tmax
Time to reach maximum observed plasma concentration
Measured: predose and multiple timepoints up to 24 hours postdose
Secondary outcomes (5)
Percentage of subjects with treatment-emergent adverse events
Measured: up to 30 days after last dose
Change from baseline in systolic and diastolic blood pressure
Measured: Up to Day 7
Change from baseline in ECG QT interval
Measured: Up to Day 7
Change from baseline in aspartate aminotransferase
Measured: Up to Day 7
Change from baseline in alanine aminotransferase
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start26 Jul 2022
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470101
- Sponsor's protocol ID
- ITI-333-003
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05470101
- Acronym / sponsor ID
- ITI-333-003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: ITI-333 2.25 mg | Experimental | Drug: ITI-333 |
| Cohort A2: ITI-333 dose to be determined based on Cohort A1 | Experimental | Drug: ITI-333 |
| Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2 | Experimental | Drug: ITI-333 |
| Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3 | Experimental | Drug: ITI-333 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-333ITI-333 oral solution | Drug | Cohort A1: ITI-333 2.25 mg, Cohort A2: ITI-333 dose to be determined based on Cohort A1, Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2, Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3 |
Primary outcome
Pharmacodynamics: 5-HT2A receptor occupancy (RO) using [11C]-MDL100907
Time frame: baseline 90-minute PET scan between Day -10 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose
Pharmacokinetics: AUC0-t
Time frame: 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
Pharmacokinetics: Cmax
Time frame: predose and multiple timepoints up to 24 hours postdose
Maximum observed plasma concentration
Pharmacokinetics: Tmax
Time frame: predose and multiple timepoints up to 24 hours postdose
Time to reach maximum observed plasma concentration
5 secondary outcomes
Percentage of subjects with treatment-emergent adverse events
Time frame: up to 30 days after last dose
Change from baseline in systolic and diastolic blood pressure
Time frame: Up to Day 7
Change from baseline in ECG QT interval
Time frame: Up to Day 7
Change from baseline in aspartate aminotransferase
Time frame: Up to Day 7
Change from baseline in alanine aminotransferase
Time frame: Up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITI-333 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamics: 5-HT2A receptor occupancy (RO) using [11C]-MDL100907 (time frame: baseline 90-minute PET scan between Day -10 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.