Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-22 @ 1:03 PM
Study NCT ID:
NCT02482935
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2015-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000590451', 'term': 'abemaciclib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All participants who received abemaciclib.', 'eventGroups': [{'id': 'EG000', 'title': 'Abemaciclib Fasted', 'description': '200 mg abemaciclib administered once, orally, in a fasted state.', 'otherNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Abemaciclib Fed', 'description': '200 mg abemaciclib administered once, orally, in a fed state.', 'otherNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib Fasted', 'description': '200 mg abemaciclib administered once, orally, in a fasted state.'}, {'id': 'OG001', 'title': 'Abemaciclib Fed', 'description': '200 mg abemaciclib administered once, orally, in a fed state.'}], 'classes': [{'title': 'Abemaciclib', 'categories': [{'measurements': [{'value': '3940', 'spread': '34', 'groupId': 'OG000'}, {'value': '4950', 'spread': '42', 'groupId': 'OG001'}]}]}, {'title': 'LSN2839567', 'categories': [{'measurements': [{'value': '1630', 'spread': '27', 'groupId': 'OG000'}, {'value': '1910', 'spread': '28', 'groupId': 'OG001'}]}]}, {'title': 'LSN3106726', 'categories': [{'measurements': [{'value': '3180', 'spread': '25', 'groupId': 'OG000'}, {'value': '3410', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period', 'unitOfMeasure': 'nanograms x hours/mililiters (ng·h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received abemaciclib and had evaluable plasma values.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib Fasted', 'description': '200 mg abemaciclib administered once, orally, in a fasted state.'}, {'id': 'OG001', 'title': 'Abemaciclib Fed', 'description': '200 mg abemaciclib administered once, orally, in a fed state.'}], 'classes': [{'title': 'Abemaciclib', 'categories': [{'measurements': [{'value': '116', 'spread': '36', 'groupId': 'OG000'}, {'value': '159', 'spread': '38', 'groupId': 'OG001'}]}]}, {'title': 'LSN2839567', 'categories': [{'measurements': [{'value': '33.4', 'spread': '36', 'groupId': 'OG000'}, {'value': '41.4', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': 'LSN3106726', 'categories': [{'measurements': [{'value': '55.7', 'spread': '31', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received abemaciclib and had evaluable plasma values.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib Fasted', 'description': '200 mg abemaciclib administered once, orally, in a fasted state.'}, {'id': 'OG001', 'title': 'Abemaciclib Fed', 'description': '200 mg abemaciclib administered once, orally, in a fed state.'}], 'classes': [{'title': 'Abemaciclib', 'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '12.00'}, {'value': '8.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '12.00'}]}]}, {'title': 'LSN2839567', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '12.00'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '12.00'}]}]}, {'title': 'LSN3106726', 'categories': [{'measurements': [{'value': '8.02', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '24.02'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '24.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received abemaciclib and had evaluable plasma values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abemaciclib Fasted/Fed', 'description': '200 milligrams (mg) abemaciclib administered orally, once in a fasted state, then once in a fed state.'}, {'id': 'FG001', 'title': 'Abemaciclib Fed/Fasted', 'description': '200 mg abemaciclib administered orally, once in a fed state, then once in a fasted state.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Received Abemaciclib', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Washout', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Received Abemaciclib', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In this two-period crossover study, abemaciclib was administered once (fasting or fed) in each period. There were at least 16 days between doses and follow-up was completed 15 to 18 days after the last dose in Period 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Abemaciclib', 'description': '200 mg abemaciclib administered once orally in each of two study periods.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', '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': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received abemaciclib.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'nctId': 'NCT03763604', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-13', 'studyFirstSubmitDate': '2015-06-24', 'resultsFirstSubmitDate': '2017-10-27', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-27', 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food. In addition, the safety and tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last about 43 days for each participant, not including screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy sterile males or surgically sterile or postmenopausal females\n* Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\\^2), inclusive\n\nExclusion Criteria:\n\n* Participated in a clinical trial involving investigational product within 30 days\n* Have known allergies to abemaciclib, related compounds or any components of the formulation, or history of significant atopy\n* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Have an abnormal blood pressure\n* Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C\n* Have donated blood of more than 500 milliliter (mL) within the last month\n* Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption 48 hours prior to each admission until collection of the last PK sample in each period\n* Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until collection of the last pharmacokinetic (PK) sample in each period\n* Are currently or have been smokers or users of tobacco or nicotine replacement products within the 6 months prior to admission or have a positive urine cotinine test\n* Are unwilling to comply with the dietary requirements/restrictions during the study: Consume only the meals provided during the inpatient stays and refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, star fruit or star fruit juice, pomelo, or commercial apple juice or orange juice for at least 2 weeks prior to the first dose until the final PK sample is collected'}, 'identificationModule': {'nctId': 'NCT02482935', 'briefTitle': 'A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'The Effect of Food on the Pharmacokinetics of the Proposed Commercial Formulation of Abemaciclib in Healthy Subjects', 'orgStudyIdInfo': {'id': '15536'}, 'secondaryIdInfos': [{'id': 'I3Y-MC-JPBU', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abemaciclib High Fat Meal', 'description': 'Abemaciclib capsules administered once orally in the fed state.', 'interventionNames': ['Drug: Abemaciclib']}, {'type': 'EXPERIMENTAL', 'label': 'Abemaciclib Fasted', 'description': 'Abemaciclib capsules administered once orally in the fasted state.', 'interventionNames': ['Drug: Abemaciclib']}], 'interventions': [{'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Administered orally', 'armGroupLabels': ['Abemaciclib Fasted', 'Abemaciclib High Fat Meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}