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

Intra-Cellular Therapies

Status and phase: Enrolling; Phase 1

Conditions: Autism Spectrum Disorder

Treatments: Drug: Lumateperone 5 mg ODT; Drug: Lumateperone 10.5 mg capsule; Drug: Lumateperone 21 mg ODT; Drug: Lumateperone 10.5 mg ODT; Drug: Lumateperone 15.5 mg ODT; Drug: Lumateperone 21 mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06557902

ITI-007-035

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Group 1 (10 to less than 13 years)

Experimental group

Description:

Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5

Treatment:

Drug: Lumateperone 21 mg capsule

Drug: Lumateperone 10.5 mg capsule

Group 2 (5 to less than 10 years)

Experimental group

Description:

Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients

Treatment:

Drug: Lumateperone 15.5 mg ODT

Drug: Lumateperone 10.5 mg ODT

Drug: Lumateperone 21 mg ODT

Drug: Lumateperone 5 mg ODT