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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06557902
The ClinicalTrials.gov registry entry for NCT06557902 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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