Autism Spectrum DisorderPhase 1NCT06557902
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
A Phase 1 study testing Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule and Lumateperone 5 mg ODT in people with Autism Spectrum Disorder, run by Intra-Cellular Therapies, Inc. at 7 sites in United States.
Trial summary
Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule and Lumateperone 5 mg ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 May 2024to 26 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients between 5 to less than 13 years of age
- Primary clinical diagnosis of ASD with symptoms of irritability
- ABC-I subscale score of ≥12 at Screening
- CGI-S score of ≥3 at Screening
- Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
- Ability to swallow capsules
Who cannot join
- Has a primary psychiatric diagnosis other than ASD
- Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses the patient to be 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
- History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) > 460 msec at Screening
- Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
- Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
CenExeli Research LLC
Atlanta, Georgia, 30030
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Core Clinical Research
Everett, Washington, 98201
Alivation Research LLC
Lincoln, Nebraska, 68526
APG Research LLC
Orlando, Florida, 32803
Midwest Research Group
Saint Charles, Missouri, 63304
CenExeli Research LLC 1
Savannah, Georgia, 31405
About this study
Official title: An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder
Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule, Lumateperone 5 mg ODT, Lumateperone 10.5 mg ODT, Lumateperone 15.5 mg ODT
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone 10.5 mg capsuleDrug
Lumateperone 10.5 mg capsule, oral administration
Lumateperone 21 mg capsuleDrug
Lumateperone 21 mg capsule, oral administration
Lumateperone 5 mg ODTDrug
Lumateperone 5 mg ODT, oral administration
Lumateperone 10.5 mg ODTDrug
Lumateperone 10.5 mg ODT, oral administration
Lumateperone 15.5 mg ODTDrug
Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration
Lumateperone 21 mg ODTDrug
Lumateperone 21 mg ODT, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (10 to less than 13 years) | Experimental | Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5 Receives: Drug: Lumateperone 10.5 mg capsule; Drug: Lumateperone 21 mg capsule |
| Group 2 (5 to less than 10 years) | Experimental | Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients Receives: Drug: Lumateperone 5 mg ODT; Drug: Lumateperone 10.5 mg ODT; Drug: Lumateperone 15.5 mg ODT; Drug: Lumateperone 21 mg ODT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Cmax
Maximum plasma concentration of lumateperone
Measured: Day 5
Pharmacokinetics: Tmax
Time of maximum plasma concentration of lumateperone
Measured: Day 5
Pharmacokinetics: AUC0-tau
Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Measured: Day 5
Secondary outcomes (8)
Percentage of patients with treatment-emergent adverse events
Measured: Up to 30 days after last dose
Change from baseline in systolic and diastolic blood presssure
Measured: Day 6
Change from baseline in ECG QT interval
Measured: Day 6
Change from baseline in hemoglobin
Measured: Day 6
Change from baseline in white blood cell count
Measured: Day 6
Change from baseline in aspartate aminotransferase
Measured: Day 6
Change from baseline in alanine aminotransferase
Measured: Day 6
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: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start10 May 2024
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT06557902
- Sponsor's protocol ID
- ITI-007-035
- Other IDs
- ITI-007-035
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06557902
- Acronym / sponsor ID
- ITI-007-035
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 16 Aug 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-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (10 to less than 13 years) | Experimental | Drug: Lumateperone 10.5 mg capsule, Drug: Lumateperone 21 mg capsuleLumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5 |
| Group 2 (5 to less than 10 years) | Experimental | Drug: Lumateperone 5 mg ODT, Drug: Lumateperone 10.5 mg ODT, Drug: Lumateperone 15.5 mg ODT, Drug: Lumateperone 21 mg ODTLumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female patients between 5 to less than 13 years of age
- Primary clinical diagnosis of ASD with symptoms of irritability
- ABC-I subscale score of ≥12 at Screening
- CGI-S score of ≥3 at Screening
- Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
Key exclusion criteria (6 listed)
- Has a primary psychiatric diagnosis other than ASD
- Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses the patient to be 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
- History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) > 460 msec at Screening
- Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
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 10.5 mg capsuleLumateperone 10.5 mg capsule, oral administration | Drug | Group 1 (10 to less than 13 years) |
| Lumateperone 21 mg capsuleLumateperone 21 mg capsule, oral administration | Drug | Group 1 (10 to less than 13 years) |
| Lumateperone 5 mg ODTLumateperone 5 mg ODT, oral administration | Drug | Group 2 (5 to less than 10 years) |
| Lumateperone 10.5 mg ODTLumateperone 10.5 mg ODT, oral administration | Drug | Group 2 (5 to less than 10 years) |
| Lumateperone 15.5 mg ODTLumateperone 5 mg ODT + 10.5 mg ODT, oral administration | Drug | Group 2 (5 to less than 10 years) |
| Lumateperone 21 mg ODTLumateperone 21 mg ODT, oral administration | Drug | Group 2 (5 to less than 10 years) |
Primary outcome
Pharmacokinetics: Cmax
Time frame: Day 5
Maximum plasma concentration of lumateperone
Pharmacokinetics: Tmax
Time frame: Day 5
Time of maximum plasma concentration of lumateperone
Pharmacokinetics: AUC0-tau
Time frame: Day 5
Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
8 secondary outcomes
Percentage of patients with treatment-emergent adverse events
Time frame: Up to 30 days after last dose
Change from baseline in systolic and diastolic blood presssure
Time frame: Day 6
Change from baseline in ECG QT interval
Time frame: Day 6
Change from baseline in hemoglobin
Time frame: Day 6
Change from baseline in white blood cell count
Time frame: Day 6
Change from baseline in aspartate aminotransferase
Time frame: Day 6
Change from baseline in alanine aminotransferase
Time frame: Day 6
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Day 6
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 24 Jul 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.
7 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 10.5 mg capsule, Lumateperone 21 mg capsule and Lumateperone 5 mg ODT in people with Autism Spectrum Disorder, run by Intra-Cellular Therapies, Inc. at 7 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 6 inclusion and 6 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 24 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 7 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 (time frame: Day 5). The study lists 3 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 24 Jul 2026.