Autism Spectrum Disorder
Conditions
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.
Interventions
DRUGLumateperone 10.5 mg capsule
Lumateperone 10.5 mg capsule, oral administration
DRUGLumateperone 21 mg capsule
Lumateperone 21 mg capsule, oral administration
DRUGLumateperone 5 mg ODT
Lumateperone 5 mg ODT, oral administration
DRUGLumateperone 10.5 mg ODT
Lumateperone 10.5 mg ODT, oral administration
DRUGLumateperone 15.5 mg ODT
Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration
DRUGLumateperone 21 mg ODT
Lumateperone 21 mg ODT, oral administration
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Cmax | Day 5 | Maximum plasma concentration of lumateperone |
| Pharmacokinetics: Tmax | Day 5 | Time of maximum plasma concentration of lumateperone |
| Pharmacokinetics: AUC0-tau | Day 5 | Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change from baseline in aspartate aminotransferase | Day 6 | — |
| Change from baseline in alanine aminotransferase | Day 6 | — |
| Change from baseline in Abnormal Involuntary Movement Scale (AIMS) | 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). |
Countries
United States
Contacts
STUDY_DIRECTORIntra-Cellular Therapies, Inc. Clinical Trial
Intra-Cellular Therapies, Inc.
Outcome results
None listed