Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:25 AM
Study NCT ID:
NCT07361367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of a Tablet Form of ABBV-722 Taken With and Without Food in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of ABBV-722', 'timeFrame': 'Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)', 'description': 'Maximum observed plasma concentration (Cmax) of ABBV-722'}, {'measure': 'Time to Cmax (Tmax) of ABBV-722', 'timeFrame': 'Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)', 'description': 'Time to Cmax (Tmax) of ABBV-722'}, {'measure': 'Terminal Phase Elimination Rate Constant (β) of ABBV-722', 'timeFrame': 'Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)', 'description': 'Terminal phase elimination rate constant of ABBV-722'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-722', 'timeFrame': 'Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)', 'description': 'Terminal phase elimination half-life of ABBV-722'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722', 'timeFrame': 'Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)', 'description': 'Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (AUCt) of ABBV-722'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722', 'timeFrame': 'Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)', 'description': 'Area under the plasma concentration-time curve from time 0 to infinite time (AUCinf) of ABBV-722'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to 57 Days', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M25-432', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the PK of a tablet formulation of ABBV-722 under fasted conditions and the effect of food on its bioavailability after administration of single doses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laboratory values meet the criteria specified in the protocol.\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* Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.\n* Use of tobacco or nicotine-containing products within 90 days prior to the first dose of study drug.\n* Prior exposure to ABBV-722 within 90 days prior to the first dose of study drug.'}, 'identificationModule': {'nctId': 'NCT07361367', 'briefTitle': 'A Phase 1 Study of a Tablet Form of ABBV-722 Taken With and Without Food in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Pharmacokinetics of a Tablet Formulation of ABBV-722 and the Effect of Food on Its Bioavailability in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'M25-432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1: Single Dose A', 'description': 'Single dose will be administered under fasted conditions', 'interventionNames': ['Drug: ABBV-722']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2: Single Dose A', 'description': 'Single dose will be administered under fed (high-fat meal) conditions', 'interventionNames': ['Drug: ABBV-722']}, {'type': 'EXPERIMENTAL', 'label': 'Period 3: Single Dose B', 'description': 'Single dose will be administered under fasted conditions', 'interventionNames': ['Drug: ABBV-722']}], 'interventions': [{'name': 'ABBV-722', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Period 1: Single Dose A', 'Period 2: Single Dose A', 'Period 3: Single Dose B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 279291', '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'}}}}