Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-30 @ 3:43 AM
Study NCT ID:
NCT05567159
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2022-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Donanemab (LY3002813) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729112', 'term': 'donanemab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800- 545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Week 22', 'description': 'All enrolled participants who received at least one IV infusion of donanemab.', 'eventGroups': [{'id': 'EG000', 'title': 'Donanemab', 'description': 'Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 22, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donanemab', 'description': 'Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.'}], 'classes': [{'title': 'Period 2', 'categories': [{'measurements': [{'value': '17300', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': 'Period 4', 'categories': [{'measurements': [{'value': '15400', 'spread': '32', 'groupId': 'OG000'}]}]}, {'title': 'Period 6', 'categories': [{'measurements': [{'value': '15500', 'spread': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71', 'description': 'As per the prespecified analysis, AUC\\[0-4 weeks\\] will be calculated as the sum of AUC0-2weeks for:\n\n* treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2\n* treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4\n* treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.', 'unitOfMeasure': 'microgram*hour per milliliter (μg*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donanemab', 'description': 'Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71', 'description': 'PK: Cmax, ss of Donanemab', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donanemab', 'description': 'Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.'}], 'classes': [{'categories': [{'measurements': [{'value': '7590', 'spread': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71', 'description': 'PK: AUCτ,ss of Donanemab', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Donanemab', 'description': 'Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'Received at Least One IV Infusion of Donanemab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Donanemab', 'description': 'Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '5.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-12', 'size': 850609, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-03T06:38', 'hasProtocol': True}, {'date': '2023-03-01', 'size': 435916, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-03T06:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07-01', 'completionDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2022-10-03', 'resultsFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-08', 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.', 'timeFrame': 'Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71', 'description': 'As per the prespecified analysis, AUC\\[0-4 weeks\\] will be calculated as the sum of AUC0-2weeks for:\n\n* treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2\n* treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4\n* treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.'}, {'measure': 'PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab', 'timeFrame': 'Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71', 'description': 'PK: Cmax, ss of Donanemab'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab', 'timeFrame': 'Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71', 'description': 'PK: AUCτ,ss of Donanemab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation\n* Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive.\n* Females of childbearing potential will be excluded from the study.\n\nExclusion Criteria:\n\n* Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone\n* Have a history within the past 5 years of a primary or recurrent malignant disease\n* Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing\n* Are pregnant or intend to become pregnant or to breastfeed during the study\n* Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions\n* Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome"}, 'identificationModule': {'nctId': 'NCT05567159', 'briefTitle': 'A Study of Donanemab (LY3002813) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants', 'orgStudyIdInfo': {'id': '18616'}, 'secondaryIdInfos': [{'id': 'I5T-MC-AACP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donanemab', 'description': 'Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.', 'interventionNames': ['Drug: Donanemab']}], 'interventions': [{'name': 'Donanemab', 'type': 'DRUG', 'otherNames': ['LY3002813'], 'description': 'Administered IV.', 'armGroupLabels': ['Donanemab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON Early Phase Services Lenexa Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}