Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Public ClinicalTrials.gov record NCT06557902. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06557902
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Interventions
- Lumateperone 10.5 mg capsule Drug
- Lumateperone 21 mg capsule Drug
- Lumateperone 5 mg ODT Drug
- Lumateperone 10.5 mg ODT Drug
- Lumateperone 15.5 mg ODT Drug
- Lumateperone 21 mg ODT Drug
Drug
Eligibility (public fields only)
- Age range
- 5 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 9, 2024
- Primary completion
- Nov 25, 2025
- Completion
- Nov 25, 2025
- Last update posted
- Jul 23, 2026
2024 – 2025
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| APG Research LLC | Orlando | Florida | 32803 | — |
| CenExeli Research LLC | Atlanta | Georgia | 30030 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| CenExeli Research LLC 1 | Savannah | Georgia | 31405 | — |
| Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Alivation Research LLC | Lincoln | Nebraska | 68526 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06557902, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06557902 live on ClinicalTrials.gov.