Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-19 @ 10:37 AM
Study NCT ID:
NCT07071532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-08', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR', 'timeFrame': 'Up to approximately 29 days', 'description': 'Cmax of ABBV-932 and active metabolites DCAR and DDCAR'}, {'measure': 'Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR', 'timeFrame': 'Up to approximately 29 days', 'description': 'Tmax of ABBV-932 and active metabolites DCAR and DDCAR'}, {'measure': 'Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR', 'timeFrame': 'Up to approximately 29 days', 'description': 'Ctrough of ABBV-932 and active metabolites DCAR and DDCAR'}, {'measure': 'Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR', 'timeFrame': 'Up to approximately 29 days', 'description': '(β) of ABBV-932 and active metabolites DCAR and DDCAR'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 and active metabolites DCAR and DDCAR', 'timeFrame': 'Up to approximately 29 days', 'description': 'Terminal phase elimination half-life of ABBV-932 and active metabolites DCAR and DDCAR'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 and active metabolites DCAR and DDCAR', 'timeFrame': 'Up to approximately 29 days', 'description': 'AUCt of ABBV-932 and active metabolites DCAR and DDCAR'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 and active metabolites DCAR and DDCAR', 'timeFrame': 'Up to approximately 29 days', 'description': 'AUCinf of ABBV-932 and active metabolites DCAR and DDCAR'}, {'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': 'Up to approximately 61 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', 'Itraconazole'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-966', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in healthy Adults participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 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* 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), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia - Suicide Severity Rating Scale (C-SSRS).'}, 'identificationModule': {'nctId': 'NCT07071532', 'briefTitle': 'A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'M24-966'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-932 with Itraconazole', 'description': 'Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.', 'interventionNames': ['Drug: ABBV-932', 'Drug: Itraconazole']}], 'interventions': [{'name': 'ABBV-932', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['ABBV-932 with Itraconazole']}, {'name': 'Itraconazole', 'type': 'DRUG', 'otherNames': ['ITZ'], 'description': 'Oral Capsule', 'armGroupLabels': ['ABBV-932 with Itraconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 276951', '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'}}}}