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NCT06557902 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
A Phase 1 study of Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 8
- Study locations
NCT06557902: Recruiting Phase 1 study of Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies.
NCT06557902 is a Phase 1 study of Autism Spectrum Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 26 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06557902, a Phase 1 study of Autism Spectrum Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
Maximum plasma concentration of lumateperone
Conditions Studied
Interventions
- DRUG 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
Study Locations (8)
Georgia
- Clinical Site 1 - Atlanta
- Clinical Site 2 - Decatur
- Clinical Site 3 - Savannah
Florida
- Clinical Site 6 - Miami
- Clinical Site 7 - Orlando
Missouri
- Clinical Site 4 - Saint Charles
Nebraska
- Clinical Site 5 - Lincoln
Washington
- Clinical Site 8 - Everett
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What NCT06557902 shows while recruiting
NCT06557902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 5 interventions - of which Lumateperone 10.5 mg capsule is the first listed.
NCT06557902 lists 8 locations in 5 states (Georgia, Florida, Missouri).
Frequently Asked Questions
What is clinical trial NCT06557902 about?
NCT06557902 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients 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.
What is the current status of trial NCT06557902?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2024-05-10. Estimated completion is 2026-07-31.
What conditions does trial NCT06557902 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT06557902?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT06557902?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06557902 being conducted?
This trial has 8 study locations across Florida, Georgia, Missouri, Nebraska, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06557902's enrollment target sits among peer trials
26 178th of 224 higher than 43 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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