Healthy VolunteersPhase 1NCT06299410
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
A Phase 1 study testing ITI-1284 10 mg and ITI-1284 20 mg in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 1 site in United States.
Trial summary
The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ITI-1284 10 mg and ITI-1284 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to 18 Aug 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between 18 and 55 years old (inclusive);
- BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
- Willingness to remain in the hospital research unit for the duration of the inpatient period.
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, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
- Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or supine pulse rate > 100 bpm or < 45 bpm at Screening;
- 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);
- Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET/CT scan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School Of Medicine
New Haven, Connecticut, 06519
About this study
Official title: An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects
The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.
Read the detailed description
This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at three dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C will evaluate the late postdose receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.
- Conditions
- Healthy Volunteers
- Being tested
- ITI-1284 10 mg, ITI-1284 20 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-1284 10 mgDrug
ITI-1284 tablet
ITI-1284 20 mgDrug
ITI-1284 tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: 10 mg ITI-1284 | Experimental | Radioligand: [11C]-raclopride Receives: Drug: ITI-1284 10 mg |
| Cohort A2: 20 mg ITI-1284 | Experimental | Radioligand: [11C]-raclopride Receives: Drug: ITI-1284 20 mg |
| Cohort A3: 30 mg ITI-1284 | Experimental | Radioligand: [11C]-raclopride Receives: Drug: ITI-1284 10 mg; Drug: ITI-1284 20 mg |
| Cohort B1: 20 mg ITI-1284 | Experimental | Radioligand: [11C]-MDL100907 Receives: Drug: ITI-1284 20 mg |
| Cohort B2: 20 mg ITI-1284 | Experimental | Radioligand: [11C]-DASB Receives: Drug: ITI-1284 20 mg |
| Cohort C1: 20 mg ITI-1284 | Experimental | Radioligand: [11C]-raclopride or [11C]-MDL100907 Receives: Drug: ITI-1284 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Receptor occupancy
Percent change of binding potential from baseline
Measured: Day 1
Secondary outcomes (7)
Pharmacokinetics: AUC0-t
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Measured: Day 1
Pharmacokinetics: Cmax
Maximum plasma concentration
Measured: Day 1
Pharmacokinetics: Tmax
Time of maximum plasma concentration
Measured: Day 1
Percentage of subjects with treatment-emergent adverse events
Measured: Up to 30 days after the dose of study drug
Change from baseline in ECG QT interval
Measured: Day 3
Change from baseline in aspartate aminotransferase
Measured: Day 3
Change from baseline in alanine aminotransferase
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start11 Apr 2024
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study includes up to 3 sequential parts (Parts A, B and C). In Part A, subjects will be assigned to 1 of 3 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan starting at 1 hour postdose. In Part B, subjects will be assigned to 1 of 2 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan starting at 1 hour postdose. In Part C, subjects will receive a single dose of ITI-1284 and undergo one postdose PET/CT scans starting at approximately 24 hours postdose.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299410
- Sponsor's protocol ID
- ITI-1284-008
- Other IDs
- ITI-1284-008
- Status last verified
- Sep 2026
- First submitted
- 1 Mar 2024
- Last updated
- 25 Sep 2026
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06299410
- Acronym / sponsor ID
- ITI-1284-008
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 7 Mar 2024 (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.
The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.
Detailed description
This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at three dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C will evaluate the late postdose receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This study includes up to 3 sequential parts (Parts A, B and C). In Part A, subjects will be assigned to 1 of 3 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan starting at 1 hour postdose. In Part B, subjects will be assigned to 1 of 2 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan starting at 1 hour postdose. In Part C, subjects will receive a single dose of ITI-1284 and undergo one postdose PET/CT scans starting at approximately 24 hours postdose.
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: 10 mg ITI-1284 | Experimental | Drug: ITI-1284 10 mgRadioligand: [11C]-raclopride |
| Cohort A2: 20 mg ITI-1284 | Experimental | Drug: ITI-1284 20 mgRadioligand: [11C]-raclopride |
| Cohort A3: 30 mg ITI-1284 | Experimental | Drug: ITI-1284 10 mg, Drug: ITI-1284 20 mgRadioligand: [11C]-raclopride |
| Cohort B1: 20 mg ITI-1284 | Experimental | Drug: ITI-1284 20 mgRadioligand: [11C]-MDL100907 |
| Cohort B2: 20 mg ITI-1284 | Experimental | Drug: ITI-1284 20 mgRadioligand: [11C]-DASB |
| Cohort C1: 20 mg ITI-1284 | Experimental | Drug: ITI-1284 20 mgRadioligand: [11C]-raclopride or [11C]-MDL100907 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects between 18 and 55 years old (inclusive);
- BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
- Willingness to remain in the hospital research unit for the duration of the inpatient period.
Key exclusion criteria (5 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, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
- Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or supine pulse rate > 100 bpm or < 45 bpm at Screening;
- 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);
- Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET/CT scan.
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-1284 10 mgITI-1284 tablet | Drug | Cohort A1: 10 mg ITI-1284, Cohort A3: 30 mg ITI-1284 |
| ITI-1284 20 mgITI-1284 tablet | Drug | Cohort A2: 20 mg ITI-1284, Cohort A3: 30 mg ITI-1284, Cohort B1: 20 mg ITI-1284, Cohort B2: 20 mg ITI-1284, Cohort C1: 20 mg ITI-1284 |
Primary outcome
% Receptor occupancy
Time frame: Day 1
Percent change of binding potential from baseline
7 secondary outcomes
Pharmacokinetics: AUC0-t
Time frame: Day 1
Pharmacokinetics: Cmax
Time frame: Day 1
Pharmacokinetics: Tmax
Time frame: Day 1
Percentage of subjects with treatment-emergent adverse events
Time frame: Up to 30 days after the dose of study drug
Change from baseline in ECG QT interval
Time frame: Day 3
Change from baseline in aspartate aminotransferase
Time frame: Day 3
Change from baseline in alanine aminotransferase
Time frame: Day 3
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 25 Sep 2026.
- 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.
Intra-Cellular Therapies, Inc. Clinical Trial study director
Intra-Cellular Therapies, Inc.
1 site 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-1284 10 mg and ITI-1284 20 mg in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 1 site 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 5 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
% Receptor occupancy (time frame: Day 1). 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 25 Sep 2026.