Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT05995366
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Mass Balance of [14C] ABBV-903 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': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax) of ABBV-903', 'timeFrame': 'Up to Day 16', 'description': 'Cmax of ABBV-903 will be assessed.'}, {'measure': 'Time to Cmax (peak time, Tmax) of ABBV-903', 'timeFrame': 'Up to Day 16', 'description': 'Tmax of ABBV-903 will be assessed.'}, {'measure': 'Terminal Phase Elimination Half-life (t1/2) of ABBV-903', 'timeFrame': 'Up to Day 16', 'description': 'Terminal phase elimination half-life (t1/2) will be assessed.'}, {'measure': 'Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903', 'timeFrame': 'Up to Day 16', 'description': 'AUC0-t of ABBV-903 will be assessed.'}, {'measure': 'AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903', 'timeFrame': 'Up to Day 16', 'description': 'AUC0-inf of ABBV-903 will be assessed.'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Baseline to Day 46', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer', 'ABBV-903'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-223', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the mass balance and safety of \\[14C\\] ABBV-903 in healthy male volunteers following a single oral dose administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body Mass Index (BMI) is \\>= 18.0 to \\<= 32.0 kg/m2 after rounding to the tenths decimal at Screening and upon initial confinement.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).\n\nExclusion Criteria:\n\n* History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness\n* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to study drug administration.\n* Consider fathering a child or donating sperm during the study and for 94 days after study drug administration.\n* Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration."}, 'identificationModule': {'nctId': 'NCT05995366', 'briefTitle': 'A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Mass Balance Study of [14C] ABBV-903 in Healthy Male Subjects Following Single Oral Dose Administration', 'orgStudyIdInfo': {'id': 'M24-223'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-903', 'description': 'Participants will receive ABBV-903 on Day 1.', 'interventionNames': ['Drug: ABBV-903']}], 'interventions': [{'name': 'ABBV-903', 'type': 'DRUG', 'description': 'Solution; Oral', 'armGroupLabels': ['ABBV-903']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit Inc. /ID# 253962', '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'}}}}