Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-26 @ 6:58 PM
Study NCT ID:
NCT06278766
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration
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': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 30 days', 'description': 'An adverse event (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.'}, {'measure': 'Maximum observed concentration (Cmax) of ABBV-552', 'timeFrame': 'Up to approximately Day 15', 'description': 'Cmax of ABBV-552 will be assessed.'}, {'measure': 'Time to Cmax (peak time, Tmax) of ABBV-552', 'timeFrame': 'Up to approximately 15 days', 'description': 'Tmax of ABBV-552 will be assessed.'}, {'measure': 'Terminal phase elimination rate constant (λz) of ABBV-552', 'timeFrame': 'Up to approximately 15 days', 'description': 'Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed.'}, {'measure': 'Terminal phase elimination half-life (t1/2) of ABBV-552', 'timeFrame': 'Up to approximately 15 days', 'description': 'Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed.'}, {'measure': 'Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552', 'timeFrame': 'Up to approximately 15 days', 'description': 'AUCt of ABBV-552 will be assessed.'}, {'measure': 'Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552', 'timeFrame': 'Up to approximately 15 days', 'description': 'AUCinf of ABBV-552 will be assessed.'}, {'measure': 'Amount of ABBV-552 excreted in the urine over the sampling period (Aeu)', 'timeFrame': 'Up to approximately 15 days', 'description': 'Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed.'}, {'measure': 'Percent of ABBV-552 excreted in the urine', 'timeFrame': 'Up to approximately 15 days', 'description': 'Percent excreted = 100 × (Aeu/dose).'}, {'measure': 'Renal clearance ABBV-552 (CLr)', 'timeFrame': 'Up to approximately 15 days', 'description': 'Renal clearance of ABBV-552 will be assessed.'}, {'measure': 'Amount of ABBV-552 excreted in the feces over the sampling period (Aef)', 'timeFrame': 'Up to approximately 15 days', 'description': 'Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed.'}, {'measure': 'Percent radioactivity excreted in the feces', 'timeFrame': 'Up to approximately 15 days', 'description': 'Percent excreted = 100 × (Aef/dose).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer', 'ABBV-552'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-416', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \\[14C\\] ABBV-552 in healthy, male volunteers following administration of a single oral dose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Male volunteers in general good health at Screening.\n\nExclusion Criteria:\n\n\\- Considering fathering a child or donating sperm during the study and for 100 days after study drug administration.'}, 'identificationModule': {'nctId': 'NCT06278766', 'briefTitle': 'A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Mass Balance Study of [14C] ABBV-552 in Healthy Male Volunteers Following Single Oral Dose Administration', 'orgStudyIdInfo': {'id': 'M24-416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-552', 'description': 'Participants will receive ABBV-552 on Day 1.', 'interventionNames': ['Drug: ABBV-552']}], 'interventions': [{'name': 'ABBV-552', 'type': 'DRUG', 'description': 'Oral Solution', 'armGroupLabels': ['ABBV-552']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit Inc /ID# 262684', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}