Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06078202
Status:
WITHDRAWN
Last Update Posted:
2024-09-20
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of ABBV-903', 'timeFrame': 'From 0 - 96 hours', 'description': 'Cmax of ABBV-903 will be assessed.'}, {'measure': 'Time to Cmax (Tmax) of ABBV-903', 'timeFrame': 'From 0 - 96 hours', 'description': 'Tmax of ABBV-903 will be assessed.'}, {'measure': 'Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903', 'timeFrame': 'From 0 - 96 hours', 'description': 'BETA of ABBV-903 will be assessed.'}, {'measure': 'Terminal Phase Elimination Half-life (t1/2) of ABBV-903', 'timeFrame': 'From 0 - 96 hours', 'description': 'Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903', 'timeFrame': 'From 0 - 96 hours', 'description': 'AUC0-24 of ABBV-903 will be assessed.'}, {'measure': 'AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903', 'timeFrame': 'From 0 - 96 hours', 'description': 'AUCt of ABBV-903 will be assessed.'}, {'measure': 'AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903', 'timeFrame': 'From 0 - 96 hours', 'description': 'AUCinf of ABBV-903 will be assessed.'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Up to 42 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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABBV-903', 'Healthy Volunteers'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-231', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 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 any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.'}, 'identificationModule': {'nctId': 'NCT06078202', 'briefTitle': 'A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'M24-231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1, Sequence A', 'description': 'Participants will receive 1 dose of ABBV-903.', 'interventionNames': ['Drug: ABBV-903']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Sequence B', 'description': 'Participants will receive 1 dose of ABBV-903.', 'interventionNames': ['Drug: ABBV-903']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Sequence C', 'description': 'Participants will receive 1 dose of ABBV-903.', 'interventionNames': ['Drug: ABBV-903']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Sequence A', 'description': 'Participants will receive 1 dose of ABBV-903.', 'interventionNames': ['Drug: ABBV-903']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Sequence B', 'description': 'Participants will receive 1 dose of ABBV-903.', 'interventionNames': ['Drug: ABBV-903']}], 'interventions': [{'name': 'ABBV-903', 'type': 'DRUG', 'description': 'Tablet; oral', 'armGroupLabels': ['Part 1, Sequence A', 'Part 1, Sequence B', 'Part 1, Sequence C', 'Part 2, Sequence A', 'Part 2, Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 259438', 'geoPoint': {'lat': 42.34447, 'lon': -88.04175}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}