Clinical trial NCT06557902: Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics: Cmax
timeFrame: Day 5
measure: Pharmacokinetics: Tmax
timeFrame: Day 5
measure: Pharmacokinetics: AUC0-tau
timeFrame: Day 5
Secondary outcomes:
measure: Percentage of patients with treatment-emergent adverse events
timeFrame: Up to 30 days after last dose
measure: Change from baseline in systolic and diastolic blood presssure
timeFrame: Day 6
measure: Change from baseline in ECG QT interval
timeFrame: Day 6
measure: Change from baseline in hemoglobin
timeFrame: Day 6
measure: Change from baseline in white blood cell count
timeFrame: Day 6
measure: Change from baseline in aspartate aminotransferase
timeFrame: Day 6
measure: Change from baseline in alanine aminotransferase
timeFrame: Day 6
measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Day 6
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Site 6
state: Florida
city: Orlando
country: United States
facility: Clinical Site 7
state: Florida
city: Atlanta
country: United States
facility: Clinical Site 1
state: Georgia
city: Decatur
country: United States
facility: Clinical Site 2
state: Georgia
city: Savannah
country: United States
facility: Clinical Site 3
state: Georgia
city: Saint Charles
country: United States
facility: Clinical Site 4
state: Missouri
city: Lincoln
country: United States
facility: Clinical Site 5
state: Nebraska
city: Everett
country: United States
facility: Clinical Site 8
state: Washington
Study officials:
References: