Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT05738850
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of ABBV-932', 'timeFrame': 'Up to approximately 5 days', 'description': 'Cmax of ABBV-932.'}, {'measure': 'Time to Cmax (Tmax) of ABBV-932', 'timeFrame': 'Up to approximately 5 days', 'description': 'Tmax of ABBV-932.'}, {'measure': 'Terminal Phase Elimination Rate Constant (Beta) of ABBV-932', 'timeFrame': 'Up to approximately 5 days', 'description': 'Terminal phase elimination rate constant (beta) of ABBV-932.'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-932', 'timeFrame': 'Up to approximately 5 days', 'description': 'Terminal phase elimination half-life of ABBV-932.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932', 'timeFrame': 'Up to approximately 5 days', 'description': 'AUCt of ABBV-932.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932', 'timeFrame': 'Up to approximately 5 days', 'description': 'AUCinf of ABBV-932.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of DCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Cmax of DCAR.'}, {'measure': 'Time to Cmax (Tmax) of DCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Tmax of DCAR.'}, {'measure': 'Terminal Phase Elimination Rate Constant (Beta) of DCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Terminal phase elimination rate constant (beta) of DCAR.'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of DCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Terminal phase elimination half-life of DCAR.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'AUCt of DCAR.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'AUCinf of DCAR.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of DDCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Cmax of DDCAR.'}, {'measure': 'Time to Cmax (Tmax) of DDCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Tmax of DDCAR.'}, {'measure': 'Terminal Phase Elimination Rate Constant (Beta) of DDCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Terminal phase elimination rate constant (beta) of DDCAR.'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of DDCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'Terminal phase elimination half-life of DDCAR.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'AUCt of DDCAR.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR', 'timeFrame': 'Up to approximately 5 days', 'description': 'AUCinf of DDCAR.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Generalized Anxiety Disorder (GAD)', 'ABBV-932'], 'conditions': ['Generalized Anxiety Disorder (GAD)', 'Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M23-889', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parts 1 and 2: Healthy individuals with body-mass index (BMI) \\>= 18.0 to \\<= 32.0 kg/m2, rounded to the tenths decimal.\n* Part 3: Healthy Japanese, Han Chinese individuals with BMI \\>= 18.0 to \\<= 30.0 kg/m2, rounded to the tenths decimal.\n* Condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead 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.'}, 'identificationModule': {'nctId': 'NCT05738850', 'briefTitle': 'Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'M23-889'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: ABBV-932', 'description': 'Participants will receive ABBV-932 on Day 1 and followed for 30 days.', 'interventionNames': ['Drug: ABBV-932']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: Placebo', 'description': 'Participants will receive placebo on Day 1 and followed for 30 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Sequence 1', 'description': 'Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days.', 'interventionNames': ['Drug: ABBV-932']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Sequence 2', 'description': 'Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days.', 'interventionNames': ['Drug: ABBV-932']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Japanese Participants: ABBV-932', 'description': 'Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.', 'interventionNames': ['Drug: ABBV-932']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 3: Japanese Participants: Placebo', 'description': 'Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Han-Chinese Participants: ABBV-932', 'description': 'Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.', 'interventionNames': ['Drug: ABBV-932']}], 'interventions': [{'name': 'ABBV-932', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Part 1: ABBV-932', 'Part 2: Sequence 1', 'Part 2: Sequence 2', 'Part 3: Han-Chinese Participants: ABBV-932', 'Part 3: Japanese Participants: ABBV-932']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Part 1: Placebo', 'Part 3: Japanese Participants: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801-2658', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials LLC /ID# 254178', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 249639', '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'}, 'collaborators': [{'name': 'Gedeon Richter Plc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}