Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT06953934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of ABBV-932', 'timeFrame': 'Up to approximately 86 days', 'description': 'Cmax of ABBV-932'}, {'measure': 'Time to Cmax (Tmax) of ABBV-932', 'timeFrame': 'Up to approximately 86 days', 'description': 'Tmax of ABBV-932'}, {'measure': 'Terminal phase elimination rate constant (λz) of ABBV-932', 'timeFrame': 'Up to approximately 86 days', 'description': 'Terminal phase elimination rate constant (λz) of ABBV-932'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-932', 'timeFrame': 'Up to approximately 86 days', 'description': 'Terminal phase elimination half-life of ABBV-932'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932', 'timeFrame': 'Up to approximately 86 days', 'description': 'AUCt of ABBV-932'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932', 'timeFrame': 'Up to approximately 86 days', 'description': 'AUCinf of ABBV-932'}, {'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': 'Up to approximately 103 days', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer', 'ABBV-932'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-991', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 18.0 to ≤ 29.9.0 kg/m\\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* Male participant who is not considering fathering a child or donating sperm during the study and for 100 days after the study drug administration\n* A condition of general good health, based upon the results of a medical history, physical exam\n\nExclusion Criteria:\n\n* Has not participated in another \\[14C\\] absorption, distribution, metabolism, excretion (ADME) study with a radiodose above 0.1 MBq in the period of 12 months prior to screening.\n* Use of any medications/products known to alter drug absorption, metabolism, or excretion processes, within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.\n* Prior exposure to ABBV-932 or cariprazine within the past 90 days.'}, 'identificationModule': {'nctId': 'NCT06953934', 'briefTitle': 'A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Mass Balance Study of [14C] ABBV-932 Following Single Oral Dose Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'M24-991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-932', 'description': 'Participants will receive a single oral dose of ABBV-932 on day 1.', 'interventionNames': ['Drug: ABBV-932']}], 'interventions': [{'name': 'ABBV-932', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['ABBV-932']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}