Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-22 @ 4:02 PM
Study NCT ID:
NCT02340104
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2015-01-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}]}}, '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': 'Baricitinib', 'description': 'Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg \\[\\^13C4D3\\^15N\\]-baricitinib over 1.5 hours', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib Oral Dose', 'description': 'Single oral dose of 4 mg baricitinib'}, {'id': 'OG001', 'title': '[^13C4D3^15N]-Baricitinib IV', 'description': 'Single intravenous (IV) infusion of 4 µg\\[\\^13C4D3\\^15N\\]-baricitinib over 1.5 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '216', 'spread': '27', 'groupId': 'OG000'}, {'value': '0.274', 'spread': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.789', 'ciLowerLimit': '0.769', 'ciUpperLimit': '0.810', 'estimateComment': 'Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose', 'description': 'AUC\\[0-∞\\] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng\\*h/mL).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Baricitinib', 'description': 'Single oral dose of 4 mg baricitinib on Day 1 and approximately the same time a single intravenous (IV) infusion of 4 µg \\[\\^13C4D3\\^15N\\]-baricitinib over 1.5 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg \\[\\^13C4D3\\^15N\\]-baricitinib over 1.5 hours.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '17.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', '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 Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2015-01-13', 'resultsFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose', 'timeFrame': 'Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose', 'description': 'AUC\\[0-∞\\] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng\\*h/mL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare how much baricitinib (study drug) gets into the blood stream when it is given as a single dose (in tablet form) and as an intravenous infusion (injection given directly into a vein via a small needle). Each participant in the study will make four visits to the investigator site over the course of about 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy males or females, as determined by medical history and physical examination\n* Male participants: agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug\n* Female participants: women not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or menopause. Menopausal women are women with spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (eg, oral contraceptives, hormones, gonadotropin releasing hormone, anti estrogens, selective estrogen receptor modulators, or chemotherapy). Menopausal status should be confirmed by a follicle stimulating hormone (FSH) level greater than 40 international units per liter (IU/L) at screening. Female participants who have been sterilized by tubal ligation will be required to use contraception from the time of screening until 28 days after the last dose of study drug\n* Have a body mass index of 18.0 to 32.0 kilogram per meter square (kg/m\\^2), inclusive, at screening\n* Have venous access sufficient to allow for blood sampling and (IV) administration of study drug\n\nExclusion Criteria:\n\n* Are participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib\n* Have known allergies to baricitinib, 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 a history or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data\n* Have a current or recent history (\\<30 days prior to screening and/or \\<45 days prior to day before study drug administration) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection\n* Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to dosing\n* Have an absolute neutrophil count (ANC) less than 2 × 109/liter (L) (2000 cells per microliter \\[cells/μL\\]) at screening or day before study drug administration. For abnormal values, a single repeat will be allowed\n* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies\n* Show evidence of hepatitis C infection and/or positive hepatitis C antibody\n* Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen\n* Are women who are pregnant or lactating\n* Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study\n* Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of occasional paracetamol, which will be permitted at the discretion of the investigator), or intended use of vitamin supplements from study drug administration until discharge from the Clinical Research Unit (CRU)'}, 'identificationModule': {'nctId': 'NCT02340104', 'briefTitle': 'A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Absolute Bioavailability Study of Baricitinib in Healthy Subjects Using the Intravenous Tracer Method', 'orgStudyIdInfo': {'id': '14610'}, 'secondaryIdInfos': [{'id': 'I4V-MC-JAGM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baricitinib', 'description': 'Single oral dose of baricitinib and single intravenous (IV) infusion of \\[\\^13C4D3\\^15N\\]-baricitinib over 1.5 hours.', 'interventionNames': ['Drug: Baricitinib', 'Drug: [^13C4D3^15N]-baricitinib']}], 'interventions': [{'name': 'Baricitinib', 'type': 'DRUG', 'otherNames': ['LY3009104'], 'description': '4 milligrams (mg) administered orally', 'armGroupLabels': ['Baricitinib']}, {'name': '[^13C4D3^15N]-baricitinib', 'type': 'DRUG', 'otherNames': ['[^13C4D3^15N]-LY3009104'], 'description': '4 micrograms (μg) administered intravenously (IV)', 'armGroupLabels': ['Baricitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], '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'}}}}