Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT05732194
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential ascending doses. Parallel (active, placebo) within each cohort'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: AUC0-tau', 'timeFrame': 'Day 14', 'description': 'Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval'}, {'measure': 'Pharmacokinetics: Cmax', 'timeFrame': 'Day 14', 'description': 'Maximum plasma concentration of ITI-333 over a dosing interval'}, {'measure': 'Pharmacokinetics: Tmax', 'timeFrame': 'Day 14', 'description': 'Time of maximum plasma concentration of ITI-333 over a dosing interval'}, {'measure': 'Percentage of subjects with treatment-emergent adverse events', 'timeFrame': 'up to 30 days after last dose'}, {'measure': 'Change from baseline in systolic and diastolic blood pressure', 'timeFrame': 'Baseline and Day 17'}, {'measure': 'Change from baseline in SpO2', 'timeFrame': 'Baseline and Day 17'}, {'measure': 'Change from baseline in ECG QT interval', 'timeFrame': 'Baseline and Day 17'}, {'measure': 'Change from baseline in aspartate aminotransferase', 'timeFrame': 'Baseline and Day 17'}, {'measure': 'Change from baseline in alanine aminotransferase', 'timeFrame': 'Baseline and Day 17'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Healthy male and female subjects between 18 and 45 years old (inclusive);\n* BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;\n* Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator.\n\nKey Exclusion Criteria:\n\n* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;\n* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \\< 96% and respiratory rate \\< 12 breaths per min;\n* History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;\n* CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1."}, 'identificationModule': {'nctId': 'NCT05732194', 'briefTitle': 'Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intra-Cellular Therapies, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ITI-333 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ITI-333-002'}, 'secondaryIdInfos': [{'id': '1UG3DA047699-02', 'type': 'NIH'}, {'id': '1UG3DA047699', 'link': 'https://reporter.nih.gov/quickSearch/1UG3DA047699', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days', 'interventionNames': ['Drug: ITI-333', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days', 'interventionNames': ['Drug: ITI-333', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days', 'interventionNames': ['Drug: ITI-333', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days', 'interventionNames': ['Drug: ITI-333', 'Other: Placebo']}], 'interventions': [{'name': 'ITI-333', 'type': 'DRUG', 'description': 'ITI-333 oral solution', 'armGroupLabels': ['Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days', 'Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days', 'Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days', 'Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching placebo', 'armGroupLabels': ['Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days', 'Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days', 'Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days', 'Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014-3616', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 1', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intra-Cellular Therapies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}