Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT05836506
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants
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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2023-04-20', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to Approximately 44 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 14 days', 'description': 'Cmax of ABBV-903'}, {'measure': 'Time to Cmax (Tmax) of ABBV-903', 'timeFrame': 'Up to approximately 14 days', 'description': 'Tmax of ABBV-903'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-903', 'timeFrame': 'Up to approximately 14 days', 'description': 'Terminal phase elimination half-life of ABBV-903'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903', 'timeFrame': 'Up to approximately 14 days', 'description': 'AUCt of ABBV-903'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903', 'timeFrame': 'Up to approximately 14 days', 'description': 'AUCinf of ABBV-903'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABBV-903', 'Healthy Volunteer'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-226', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 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 at screening visit 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 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': 'NCT05836506', 'briefTitle': 'A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Assessment of the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'M24-226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Sequence A', 'description': 'In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after a high fat meal. Participants will be followed up for 30 days.', 'interventionNames': ['Drug: ABBV-903 Tablet Form 1', 'Drug: ABBV-903 Tablet Form 2']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Sequence B', 'description': 'In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Participants will be followed up for 30 days.', 'interventionNames': ['Drug: ABBV-903 Tablet Form 1', 'Drug: ABBV-903 Tablet Form 2']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Sequence A', 'description': 'In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after a high fat meal. Participants will be followed up for 30 days.', 'interventionNames': ['Drug: ABBV-903 Tablet Form 1', 'Drug: ABBV-903 Tablet Form 2']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Sequence B', 'description': 'In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Participants will be followed up for 30 days.', 'interventionNames': ['Drug: ABBV-903 Tablet Form 1', 'Drug: ABBV-903 Tablet Form 2']}], 'interventions': [{'name': 'ABBV-903 Tablet Form 1', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['Part 1: Sequence A', 'Part 1: Sequence B', 'Part 2: Sequence A', 'Part 2: Sequence B']}, {'name': 'ABBV-903 Tablet Form 2', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['Part 1: Sequence A', 'Part 1: Sequence B', 'Part 2: Sequence A', 'Part 2: Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 254926', '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'}}}}