Schizophrenia or SchizoaffectivePhase 1NCT06627413
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
A Phase 1 study testing Lumateperone Capsule and Lumateperone LAI in people with Schizophrenia or Schizoaffective, run by Intra-Cellular Therapies, Inc. at 4 sites in United States.
Trial summary
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia or Schizoaffective
- What is being tested?
- Lumateperone Capsule and Lumateperone LAI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Aug 2024to 20 Nov 2025
- 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
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Male or female patients between 18 and 55 years of age, inclusive;
- Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening;
- Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1;
- Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening.
Main Exclusion Criteria:
- History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study;
- Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others;
- Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables;
- Has a QT interval corrected for heart rate using Fridericia formula > 450 msec in males or > 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CenExeli Research LLC
Atlanta, Georgia, 30030
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
Hassman Research Institute, LLC.
Marlton, New Jersey, 08053
About this study
Official title: A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
- Conditions
- Schizophrenia or Schizoaffective
- Being tested
- Lumateperone Capsule, Lumateperone LAI
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone CapsuleDrug
Lumateperone 42 mg capsule, oral administration
Lumateperone LAIDrug
Lumateperone LAI X500-E2 IM injection
Lumateperone LAIDrug
Lumateperone LAI X500-E3 IM injection
Lumateperone LAIDrug
Lumateperone LAI X500-X2 IM injection
Lumateperone LAIDrug
Lumateperone LAI X500-X5 IM injection
Lumateperone LAIDrug
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E2 after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 2 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E3 after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 3 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X2 after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 4 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X5 after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 5 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 6 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 7 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 8 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
| Cohort 9 | Experimental | Lumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout Receives: Drug: Lumateperone Capsule; Drug: Lumateperone LAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Cmax,oral
Maximum plasma concentration of lumateperone
Measured: Day 5
Pharmacokinetics: Cmax,IM
Maximum plasma concentration of lumateperone
Measured: Day 11-60
Pharmacokinetics: Tmax,oral
Time of maximum concentration of lumateperone in plasma
Measured: Day 5
Pharmacokinetics: Tmax,IM
Time of maximum concentration of lumateperone in plasma
Measured: Day 11-60
Pharmacokinetics: AUC0-t,oral
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Measured: Day 5
Pharmacokinetics: AUC0-t,IM
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Measured: Day 11-60
Secondary outcomes (8)
Percentage of subjects with treatment-emergent adverse events
Measured: up to 30 days after the last protocol-defined study visit
Change from baseline in systolic and diastolic blood pressure
Measured: Days 25 and 60
Change from baseline in ECG QTcF interval
Measured: Days 25 and 60
Change from baseline in hemoglobin
Measured: Days 25 and 60
Change from baseline in white blood cell count
Measured: Days 25 and 60
Change from baseline in aspartate aminotransferase
Measured: Days 25 and 60
Change from baseline in alanine aminotransferase
Measured: Days 25 and 60
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4).
Measured: Days 25 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start23 Aug 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia or SchizoaffectiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study includes 3 sequential study parts (Parts A, B and C). Part A consists of 4 cohorts (Cohorts 1 to 4), Part B of up to 3 cohorts (Cohorts 5 to 7), and Part C of up to 2 cohorts (Cohorts 8 and 9). Within each study part, cohorts may be enrolled in parallel.
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT06627413
- Sponsor's protocol ID
- ITI-007-037
- Other IDs
- ITI-007-037
- Status last verified
- Jul 2026
- First submitted
- 2 Oct 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT06627413
- Acronym / sponsor ID
- ITI-007-037
- Conditions
- Schizophrenia or Schizoaffective
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 4 Oct 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.
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- This study includes 3 sequential study parts (Parts A, B and C). Part A consists of 4 cohorts (Cohorts 1 to 4), Part B of up to 3 cohorts (Cohorts 5 to 7), and Part C of up to 2 cohorts (Cohorts 8 and 9). Within each study part, cohorts may be enrolled in parallel.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E2 after a 5-day washout |
| Cohort 2 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E3 after a 5-day washout |
| Cohort 3 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X2 after a 5-day washout |
| Cohort 4 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X5 after a 5-day washout |
| Cohort 5 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout |
| Cohort 6 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout |
| Cohort 7 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout |
| Cohort 8 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout |
| Cohort 9 | Experimental | Drug: Lumateperone Capsule, Drug: Lumateperone LAILumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Lumateperone CapsuleLumateperone 42 mg capsule, oral administration | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
| Lumateperone LAILumateperone LAI X500-E2 IM injection | Drug | Cohort 1 |
| Lumateperone LAILumateperone LAI X500-E3 IM injection | Drug | Cohort 2 |
| Lumateperone LAILumateperone LAI X500-X2 IM injection | Drug | Cohort 3 |
| Lumateperone LAILumateperone LAI X500-X5 IM injection | Drug | Cohort 4 |
| Lumateperone LAILumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection | Drug | Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Pharmacokinetics: Cmax,oral
Time frame: Day 5
Maximum plasma concentration of lumateperone
Pharmacokinetics: Cmax,IM
Time frame: Day 11-60
Maximum plasma concentration of lumateperone
Pharmacokinetics: Tmax,oral
Time frame: Day 5
Time of maximum concentration of lumateperone in plasma
Pharmacokinetics: Tmax,IM
Time frame: Day 11-60
Time of maximum concentration of lumateperone in plasma
Pharmacokinetics: AUC0-t,oral
Time frame: Day 5
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Pharmacokinetics: AUC0-t,IM
Time frame: Day 11-60
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
8 secondary outcomes
Percentage of subjects with treatment-emergent adverse events
Time frame: up to 30 days after the last protocol-defined study visit
Change from baseline in systolic and diastolic blood pressure
Time frame: Days 25 and 60
Change from baseline in ECG QTcF interval
Time frame: Days 25 and 60
Change from baseline in hemoglobin
Time frame: Days 25 and 60
Change from baseline in white blood cell count
Time frame: Days 25 and 60
Change from baseline in aspartate aminotransferase
Time frame: Days 25 and 60
Change from baseline in alanine aminotransferase
Time frame: Days 25 and 60
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Days 25 and 60
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 31 Jul 2026.
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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.
4 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 Lumateperone Capsule and Lumateperone LAI in people with Schizophrenia or Schizoaffective, run by Intra-Cellular Therapies, Inc. at 4 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?
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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Pharmacokinetics: Cmax,oral (time frame: Day 5). The study lists 6 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 31 Jul 2026.