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

NCT06557902 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ITI-007-035
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 8

Brief 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

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics: Cmax

  Maximum plasma concentration of lumateperone

  Day 5

• Pharmacokinetics: Tmax

  Time of maximum plasma concentration of lumateperone

  Day 5

• Pharmacokinetics: AUC0-tau

  Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)

  Day 5

Secondary Outcomes (8)

• Percentage of patients with treatment-emergent adverse events

  Up to 30 days after last dose

• Change from baseline in systolic and diastolic blood presssure

  Day 6

• Change from baseline in ECG QT interval

  Day 6

• Change from baseline in hemoglobin

  Day 6

• Change from baseline in white blood cell count

  Day 6

Study Arms (2)

Group 1 (10 to less than 13 years)

EXPERIMENTAL

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

Drug: Lumateperone 10.5 mg capsule; Drug: Lumateperone 21 mg capsule

Group 2 (5 to less than 10 years)

EXPERIMENTAL

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

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

Interventions

Lumateperone 10.5 mg capsule DRUG

Lumateperone 10.5 mg capsule, oral administration

Group 1 (10 to less than 13 years)

Lumateperone 21 mg capsule DRUG

Lumateperone 21 mg capsule, oral administration

Group 1 (10 to less than 13 years)

Lumateperone 5 mg ODT DRUG

Lumateperone 5 mg ODT, oral administration

Group 2 (5 to less than 10 years)

Lumateperone 10.5 mg ODT DRUG

Lumateperone 10.5 mg ODT, oral administration

Group 2 (5 to less than 10 years)

Lumateperone 15.5 mg ODT DRUG

Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration

Group 2 (5 to less than 10 years)

Lumateperone 21 mg ODT DRUG

Lumateperone 21 mg ODT, oral administration

Group 2 (5 to less than 10 years)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (8)

Clinical Site 6

Miami, Florida, 33133, United States

NOT YET RECRUITING

Clinical Site 7

Orlando, Florida, 32803, United States

NOT YET RECRUITING

Clinical Site 1

Atlanta, Georgia, 30331, United States

RECRUITING

Clinical Site 2

Decatur, Georgia, 30030, United States

RECRUITING

Clinical Site 3

Savannah, Georgia, 31405, United States

RECRUITING

Clinical Site 4

Saint Charles, Missouri, 63304, United States

RECRUITING

Clinical Site 5

Lincoln, Nebraska, 68526, United States

RECRUITING

Clinical Site 8

Everett, Washington, 98201, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

ITI Clinical Trials

CONTACT

6464409333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)