Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-03 @ 2:14 PM
Study NCT ID:
NCT06557902
Status:
RECRUITING
Last Update Posted:
2024-08-16
First Post:
2024-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705749', 'term': 'lumateperone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Cmax', 'timeFrame': 'Day 5', 'description': 'Maximum plasma concentration of lumateperone'}, {'measure': 'Pharmacokinetics: Tmax', 'timeFrame': 'Day 5', 'description': 'Time of maximum plasma concentration of lumateperone'}, {'measure': 'Pharmacokinetics: AUC0-tau', 'timeFrame': 'Day 5', 'description': 'Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)'}], 'secondaryOutcomes': [{'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', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients between 5 to less than 13 years of age\n* Primary clinical diagnosis of ASD with symptoms of irritability\n* ABC-I subscale score of ≥12 at Screening\n* CGI-S score of ≥3 at Screening\n* Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening\n* Ability to swallow capsules\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than ASD\n* 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\n* 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\n* 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\n* Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening\n* 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"}, 'identificationModule': {'nctId': 'NCT06557902', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intra-Cellular Therapies, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ITI-007-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (10 to less than 13 years)', 'description': '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', 'interventionNames': ['Drug: Lumateperone 10.5 mg capsule', 'Drug: Lumateperone 21 mg capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (5 to less than 10 years)', 'description': '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', 'interventionNames': ['Drug: Lumateperone 5 mg ODT', 'Drug: Lumateperone 10.5 mg ODT', 'Drug: Lumateperone 15.5 mg ODT', 'Drug: Lumateperone 21 mg ODT']}], 'interventions': [{'name': 'Lumateperone 10.5 mg capsule', 'type': 'DRUG', 'description': 'Lumateperone 10.5 mg capsule, oral administration', 'armGroupLabels': ['Group 1 (10 to less than 13 years)']}, {'name': 'Lumateperone 21 mg capsule', 'type': 'DRUG', 'description': 'Lumateperone 21 mg capsule, oral administration', 'armGroupLabels': ['Group 1 (10 to less than 13 years)']}, {'name': 'Lumateperone 5 mg ODT', 'type': 'DRUG', 'description': 'Lumateperone 5 mg ODT, oral administration', 'armGroupLabels': ['Group 2 (5 to less than 10 years)']}, {'name': 'Lumateperone 10.5 mg ODT', 'type': 'DRUG', 'description': 'Lumateperone 10.5 mg ODT, oral administration', 'armGroupLabels': ['Group 2 (5 to less than 10 years)']}, {'name': 'Lumateperone 15.5 mg ODT', 'type': 'DRUG', 'description': 'Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration', 'armGroupLabels': ['Group 2 (5 to less than 10 years)']}, {'name': 'Lumateperone 21 mg ODT', 'type': 'DRUG', 'description': 'Lumateperone 21 mg ODT, oral administration', 'armGroupLabels': ['Group 2 (5 to less than 10 years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 6', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 7', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 1', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 2', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 3', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '63304', 'city': 'Saint Charles', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 4', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 5', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Site 8', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}], 'centralContacts': [{'name': 'ITI Clinical Trials', 'role': 'CONTACT', 'email': 'ITCIClinicalTrials@itci-inc.com', 'phone': '6464409333'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intra-Cellular Therapies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}