Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-29 @ 3:52 AM
Study NCT ID:
NCT05895266
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 40 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.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of ABBV-903', 'timeFrame': 'Up to approximately 40 days', 'description': 'Cmax of ABBV-903'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'Cmax of midazolam'}, {'measure': 'Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'Cmax of 1-OH-midazolam'}, {'measure': 'Time to Cmax (Tmax) of ABBV-903', 'timeFrame': 'Up to approximately 40 days', 'description': 'Tmax of ABBV-903'}, {'measure': 'Time to Cmax (Tmax) of Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'Tmax of midazolam'}, {'measure': 'Time to Cmax (Tmax) of 1-OH-Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'Tmax of 1-OH-midazolam'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-903', 'timeFrame': 'Up to approximately 40 days', 'description': 'Terminal phase elimination half-life of ABBV-903'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'Terminal phase elimination half-life of midazolam'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'Terminal phase elimination half-life of 1-OH-midazolam'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903', 'timeFrame': 'Up to approximately 40 days', 'description': 'AUCt of ABBV-903'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'AUCt of midazolam'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'AUCt of 1-OH-midazolam'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903', 'timeFrame': 'Up to approximately 40 days', 'description': 'AUCinf of ABBV-903'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'AUCinf of midazolam'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam', 'timeFrame': 'Up to approximately 40 days', 'description': 'AUCinf of 1-OH-midazolam'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer', 'ABBV-903', 'Midazolam'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-225', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.\n* Negative test result for SARS-CoV-2 infection 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 ECG.\n\nExclusion Criteria:\n\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.\n* History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.'}, 'identificationModule': {'nctId': 'NCT05895266', 'briefTitle': 'A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam', 'orgStudyIdInfo': {'id': 'M24-225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Period 1', 'description': 'In Period 1 on Day 1, participants will receive liquid midazolam.', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Period 2', 'description': 'In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.', 'interventionNames': ['Drug: ABBV-903', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Period 1', 'description': 'In Period 1 on Day 1, participants will receive liquid midazolam.', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Period 2', 'description': 'In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.', 'interventionNames': ['Drug: ABBV-903', 'Drug: Midazolam']}], 'interventions': [{'name': 'ABBV-903', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Part 1: Period 2', 'Part 2: Period 2']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Oral Liquid', 'armGroupLabels': ['Part 1: Period 1', 'Part 1: Period 2', 'Part 2: Period 1', 'Part 2: Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 254970', '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'}}}}