# Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

> **NCT06557902** · PHASE1 · RECRUITING · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 26 (estimated)

## Conditions studied

- Autism Spectrum Disorder

## 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
- **DRUG:** Lumateperone 21 mg ODT

## Key facts

- **NCT ID:** NCT06557902
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2024-05-10
- **Primary completion:** 2026-07-31
- **Final completion:** 2026-07-31
- **Target enrollment:** 26 (ESTIMATED)
- **Last updated:** 2024-08-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06557902

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06557902, "Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT06557902. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*