Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-09 @ 7:57 PM
Study NCT ID:
NCT02217618
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2014-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY2409021 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601762', 'term': 'adomeglivant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LY2409021', 'description': 'Single oral dose of 20 mg LY2409021.', 'otherNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2409021', 'description': 'Single oral dose of 20 mg LY2409021.'}], 'classes': [{'categories': [{'measurements': [{'value': '48100', 'spread': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose', 'description': 'Area under the concentration versus time curve from zero to infinity (AUC\\[0-inf\\]) of LY2409021 is presented.', 'unitOfMeasure': 'nanogram*hours per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of study drug and had evaluable AUC(0-inf) data.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2409021', 'description': 'Single oral dose of 20 mg LY2409021.'}], 'classes': [{'categories': [{'measurements': [{'value': '625', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of study drug and had evaluable Cmax data.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2409021', 'description': 'Single oral dose of 20 mg LY2409021.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '24.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of study drug and had evaluable Tmax data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2409021', 'description': 'Single oral dose of 20 milligrams (mg) LY2409021.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2409021', 'description': 'Single oral dose of 20 mg LY2409021.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', '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': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-24', 'studyFirstSubmitDate': '2014-08-13', 'resultsFirstSubmitDate': '2018-03-24', 'studyFirstSubmitQcDate': '2014-08-13', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-24', 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose', 'description': 'Area under the concentration versus time curve from zero to infinity (AUC\\[0-inf\\]) of LY2409021 is presented.'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose'}, {'measure': 'Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females as determined by medical history\n* Satisfactory clinical laboratory and physical examination tests\n* Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m\\^2)\n\nExclusion Criteria:\n\n\\- Abnormal electrocardiograms (ECGs)'}, 'identificationModule': {'nctId': 'NCT02217618', 'briefTitle': 'A Study of LY2409021 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Single Dose Pharmacokinetic Study of LY2409021 Tablet Administered in Healthy Subjects', 'orgStudyIdInfo': {'id': '14580'}, 'secondaryIdInfos': [{'id': 'I1R-MC-GLDL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2409021', 'description': 'Single oral dose of 20 milligrams (mg) LY2409021.', 'interventionNames': ['Drug: LY2409021']}], 'interventions': [{'name': 'LY2409021', 'type': 'DRUG', 'armGroupLabels': ['LY2409021']}]}, 'contactsLocationsModule': {'locations': [{'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'}}}}