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

August 14, 2024 updated by: Intra-Cellular Therapies, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33133
        • Not yet recruiting
        • Clinical Site 6
      • Orlando, Florida, United States, 32803
        • Not yet recruiting
        • Clinical Site 7
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Clinical Site 1
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Clinical Site 2
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Clinical Site 3
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Clinical Site 4
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Clinical Site 5
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Clinical Site 8

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 (10 to less than 13 years)
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
Lumateperone 10.5 mg capsule, oral administration
Drug: Lumateperone 21 mg capsule
Lumateperone 21 mg capsule, oral administration
Experimental: Group 2 (5 to less than 10 years)
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Cmax
Time Frame: Day 5
Maximum plasma concentration of lumateperone
Day 5
Pharmacokinetics: Tmax
Time Frame: Day 5
Time of maximum plasma concentration of lumateperone
Day 5
Pharmacokinetics: AUC0-tau
Time Frame: Day 5
Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in ECG QT interval
Time Frame: Day 6
Day 6
Change from baseline in hemoglobin
Time Frame: Day 6
Day 6
Change from baseline in white blood cell count
Time Frame: Day 6
Day 6
Change from baseline in aspartate aminotransferase
Time Frame: Day 6
Day 6
Change from baseline in alanine aminotransferase
Time Frame: Day 6
Day 6
Percentage of patients with treatment-emergent adverse events
Time Frame: Up to 30 days after last dose
Up to 30 days after last dose
Change from baseline in systolic and diastolic blood presssure
Time Frame: Day 6
Day 6
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time Frame: Day 6
AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4).
Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITI-007-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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