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

Description

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

Autism Spectrum Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Miami

Clinical Site 6, Miami, Florida, United States, 33133

Orlando

Clinical Site 7, Orlando, Florida, United States, 32803

Atlanta

Clinical Site 1, Atlanta, Georgia, United States, 30331

Decatur

Clinical Site 2, Decatur, Georgia, United States, 30030

Savannah

Clinical Site 3, Savannah, Georgia, United States, 31405

Saint Charles

Clinical Site 4, Saint Charles, Missouri, United States, 63304

Lincoln

Clinical Site 5, Lincoln, Nebraska, United States, 68526

Everett

Clinical Site 8, Everett, Washington, United States, 98201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female patients between 5 to less than 13 years of age
  • * Primary clinical diagnosis of ASD with symptoms of irritability
  • * ABC-I subscale score of ≥12 at Screening
  • * CGI-S score of ≥3 at Screening
  • * Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
  • * Ability to swallow capsules
  • * Has a primary psychiatric diagnosis other than ASD
  • * Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses the patient to be a safety risk to him/herself or others
  • * Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
  • * History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \> 460 msec at Screening
  • * Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
  • * Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures

Ages Eligible for Study

5 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Intra-Cellular Therapies, Inc.,

Study Record Dates

2026-07-31