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

ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5-12
SponsorIntra-Cellular Therapies, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lumateperone 10.5 mg capsule

    Drug

    Lumateperone 10.5 mg capsule, oral administration

  • Lumateperone 21 mg capsule

    Drug

    Lumateperone 21 mg capsule, oral administration

  • Lumateperone 5 mg ODT

    Drug

    Lumateperone 5 mg ODT, oral administration

  • Lumateperone 10.5 mg ODT

    Drug

    Lumateperone 10.5 mg ODT, oral administration

  • Lumateperone 15.5 mg ODT

    Drug

    Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration

  • Lumateperone 21 mg ODT

    Drug

    Lumateperone 21 mg ODT, oral administration

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Group 1 (10 to less than 13 years)Experimental treatment 2 interventions
Group B: Group 2 (5 to less than 10 years)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pharmacokinetics: Cmax

Maximum plasma concentration of lumateperone

Time frame
Day 5
2

Pharmacokinetics: Tmax

Time of maximum plasma concentration of lumateperone

Time frame
Day 5
3

Pharmacokinetics: AUC0-tau

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

Time frame
Day 5

Secondary outcomes

1

Percentage of patients with treatment-emergent adverse events

Time frame
Up to 30 days after last dose
2

Change from baseline in systolic and diastolic blood presssure

Time frame
Day 6
3

Change from baseline in ECG QT interval

Time frame
Day 6
4

Change from baseline in hemoglobin

Time frame
Day 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intra-Cellular Therapies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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