Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-04-04 @ 3:09 AM
Study NCT ID:
NCT01810432
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2013-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Food on Evacetrapib (LY2484595) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C568301', 'term': 'evacetrapib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': 'Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Evacetrapib (Fasted)', 'description': 'Participants received 130-mg oral tablet fo evacetrapib QD in a fasted state for 10 days.', 'otherNumAtRisk': 39, 'otherNumAffected': 7, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Evacetrapib (Fed)', 'description': 'Participants received 130-mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.', 'otherNumAtRisk': 39, 'otherNumAffected': 4, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib (Fasted)', 'description': 'Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.'}, {'id': 'OG001', 'title': 'Evacetrapib (Fed)', 'description': 'Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1140', 'spread': '73', 'groupId': 'OG000'}, {'value': '1720', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose', 'unitOfMeasure': 'nanograms/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with evaluable Cmax data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib (Fasted)', 'description': 'Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.'}, {'id': 'OG001', 'title': 'Evacetrapib (Fed)', 'description': 'Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '9930', 'spread': '49', 'groupId': 'OG000'}, {'value': '14400', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose', 'unitOfMeasure': 'nanograms*hour/milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with evaluable AUCτ data.'}, {'type': 'PRIMARY', 'title': 'PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib (Fasted)', 'description': 'Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.'}, {'id': 'OG001', 'title': 'Evacetrapib (Fed)', 'description': 'Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.03'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with evaluable tmax data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1 (Fast/Fed)', 'description': 'Participants received a 130 milligram (mg) oral tablet of evacetrapib once daily (QD) for 10 days (Period 1) in a fasted state. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.'}, {'id': 'FG001', 'title': 'Sequence 2 (Fed/Fasted)', 'description': 'Participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Evacetrapib', 'description': 'Sequence 1-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) in a fasted state. Following a 14-day washout period, participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.\n\nSequence 2-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', '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': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2013-03-11', 'resultsFirstSubmitDate': '2018-02-18', 'studyFirstSubmitQcDate': '2013-03-11', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-10', 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib', 'timeFrame': 'Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib', 'timeFrame': 'Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib', 'timeFrame': 'Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.\n\nThe study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.\n\nThis study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants as determined by medical history and physical examination\n* Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)\n* Are able to eat a high fat breakfast and abide by the food restrictions throughout the study\n\nExclusion Criteria:\n\n* Have known allergies to evacetrapib, related compounds or any components of the formulation\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* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening\n* Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes'}, 'identificationModule': {'nctId': 'NCT01810432', 'briefTitle': 'Study of Food on Evacetrapib (LY2484595) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects', 'orgStudyIdInfo': {'id': '14626'}, 'secondaryIdInfos': [{'id': 'I1V-MC-EIAX', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evacetrapib (Fasted)', 'description': '130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.', 'interventionNames': ['Drug: Evacetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Evacetrapib (Fed)', 'description': '130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.', 'interventionNames': ['Drug: Evacetrapib', 'Other: High-fat Meal']}], 'interventions': [{'name': 'Evacetrapib', 'type': 'DRUG', 'otherNames': ['LY2484595'], 'description': 'Administered orally', 'armGroupLabels': ['Evacetrapib (Fasted)', 'Evacetrapib (Fed)']}, {'name': 'High-fat Meal', 'type': 'OTHER', 'description': 'Administered orally, at breakfast.', 'armGroupLabels': ['Evacetrapib (Fed)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], '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'}}}}