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

NCT06557902 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-08-16

No results posted yet for this 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

Interventions

DRUG

Lumateperone 10.5 mg capsule

Lumateperone 10.5 mg capsule, oral administration

DRUG

Lumateperone 21 mg capsule

Lumateperone 21 mg capsule, oral administration

DRUG

Lumateperone 5 mg ODT

Lumateperone 5 mg ODT, oral administration

DRUG

Lumateperone 10.5 mg ODT

Lumateperone 10.5 mg ODT, oral administration

DRUG

Lumateperone 15.5 mg ODT

Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration

DRUG

Lumateperone 21 mg ODT

Lumateperone 21 mg ODT, oral administration

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06557902 on ClinicalTrials.gov