Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-03-01 @ 12:20 AM
Study NCT ID:
NCT02156492
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C568301', 'term': 'evacetrapib'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Evacetrapib Single Cohort A', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Evacetrapib Multiple', 'description': 'Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Simvastatin', 'description': 'Part 2, Cohorts B, Period 1, Participants will receive simvastatin 40 mg orally, once daily on Days 1 - 4.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Evacetrapib Single Cohort B', 'description': 'Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Evacetrapib and Simvastatin', 'description': 'Part 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Atorvastatin', 'description': 'Part 2, Cohorts C, Period 1, Participants will receive atorvastatin orally, once daily on Days 1 - 4.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Evacetrapib Single Cohort C', 'description': 'Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Evacetrapib and Atorvastatin', 'description': 'Part 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib Single and Multiple Dose', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.\n\nPart 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '7700', 'spread': '74', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '23600', 'spread': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose', 'description': 'Pharmacokinetic (PK) parameter estimates from evacetrapib concentrations following single dose and daily dose of 130 mg evacetrapib.', 'unitOfMeasure': 'nanogram * hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Cohort A.'}, {'type': 'PRIMARY', 'title': 'PK: Maximum Concentration (Cmax) of Evacetrapib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib Single and Multiple Dose', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.\n\nPart 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.'}], 'classes': [{'title': 'Single Dose Day 1', 'categories': [{'measurements': [{'value': '418', 'spread': '118', 'groupId': 'OG000'}]}]}, {'title': 'Multiple Dose Day 14', 'categories': [{'measurements': [{'value': '954', 'spread': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose', 'description': 'Pharmacokinetic parameter estimates from evacetrapib following single dose and daily doses of 130 mg.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Cohort A.'}, {'type': 'PRIMARY', 'title': 'PK: Time to Maximum Concentration (Tmax) of Evacetrapib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib Single and Multiple Dose', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.\n\nPart 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.'}], 'classes': [{'title': 'Single Dose Day 1', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '6.00'}]}]}, {'title': 'Daily Dose Day 14', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.', 'description': 'Pharmacokinetic parameter estimates of evacetrapib following single and daily doses of 130 mg evacetrapib.', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Cohort A.'}, {'type': 'PRIMARY', 'title': 'PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib Daily and Simvastatin', 'description': 'Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14.\n\nPart 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22.'}, {'id': 'OG001', 'title': 'Evacetrapib Daily and Atorvastatin', 'description': 'Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14.\n\nPart 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22.'}], 'classes': [{'title': 'Days 5-14', 'categories': [{'measurements': [{'value': '10700', 'spread': '36', 'groupId': 'OG000'}, {'value': '10600', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Days 15-22', 'categories': [{'measurements': [{'value': '9640', 'spread': '48', 'groupId': 'OG000'}, {'value': '9480', 'spread': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose', 'description': 'Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily AUC (0-24).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Cohort B and C and had evaluable PK data'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Evacetrapib Alone and With Simvastatin or Atorvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib Daily and Simvastatin', 'description': 'Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14.\n\nPart 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22.'}, {'id': 'OG001', 'title': 'Evactrapib Daily and Atorvastatin', 'description': 'Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14.\n\nPart 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22.'}], 'classes': [{'title': 'Days 5-14', 'categories': [{'measurements': [{'value': '1180', 'spread': '52', 'groupId': 'OG000'}, {'value': '1120', 'spread': '36', 'groupId': 'OG001'}]}]}, {'title': 'Days 15- 22', 'categories': [{'measurements': [{'value': '1020', 'spread': '68', 'groupId': 'OG000'}, {'value': '1000', 'spread': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.', 'description': 'Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Cohort B and C and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Tmax of Evacetrapib Alone and With Simvastatin or Atorvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib Daily and Simvastatin', 'description': 'Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14\n\nPart 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22.'}, {'id': 'OG001', 'title': 'Evacetrapib Daily and Atrovastatin', 'description': 'Part 2, Cohort C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14\n\nPart 2, Cohort C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22.'}], 'classes': [{'title': 'Days 5-14', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '6.00'}]}]}, {'title': 'Days 15- 22', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.', 'description': 'Pharmacokinetic parameter estimates of Tmax of evacetrapib following 130 mg daily dose alone or with 40 mg Simvastatin or 20 mg Atorvastatin. Tmax of simvastatin and atorvastatin.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Cohort B and C and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Effect of Evacetrapib Single and Multiple Doses on High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evacetrapib Single Dose Day 2', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.'}, {'id': 'OG001', 'title': 'Evacetrapib Multiple Dose Day 22', 'description': 'Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.'}], 'classes': [{'title': 'HDL-C', 'categories': [{'measurements': [{'value': '1.641', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '2.676', 'spread': '0.373', 'groupId': 'OG001'}]}]}, {'title': 'LDL-C', 'categories': [{'measurements': [{'value': '2.289', 'spread': '0.483', 'groupId': 'OG000'}, {'value': '1.241', 'spread': '0.574', 'groupId': 'OG001'}]}]}, {'title': 'TG', 'categories': [{'measurements': [{'value': '0.984', 'spread': '0.312', 'groupId': 'OG000'}, {'value': '1.221', 'spread': '0.356', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Dose Day 2 and Multiple Dose Day 22', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Cohort A.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: Evacetrapib Single and Multiple Dose', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.\n\nPart 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.'}, {'id': 'FG001', 'title': 'Cohort B: Evacetrapib and Simvastatin', 'description': 'Part 2, Cohorts B, Period 1, Participants will receive simvastatin 40 mg orally, once daily on Days 1 - 4\n\nPart 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14\n\nPart 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22.'}, {'id': 'FG002', 'title': 'Cohort C: Evacetrapib and Atorvastatin', 'description': 'Part 2, Cohorts C, Period 1, Participants will receive atorvastatin orally, once daily on Days 1 - 4.\n\nPart 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14\n\nPart 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'No Reason Given', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Cohort A participated in Period 1 and Period 2 only.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.\n\nPart 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.'}, {'id': 'BG001', 'title': 'Cohort B', 'description': 'Part 2, Cohorts B, Period 1, Participants will receive simvastatin 40 mg orally, once daily on Days 1 - 4.\n\nPart 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14\n\nPart 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22.'}, {'id': 'BG002', 'title': 'Cohort C', 'description': 'Part 2, Cohorts C, Period 1, Participants will receive atorvastatin orally, once daily on Days 1 - 4.\n\nPart 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14\n\nPart 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '27.9', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '28.02', 'spread': '5.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-18', 'studyFirstSubmitDate': '2014-05-28', 'resultsFirstSubmitDate': '2018-02-18', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-18', 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib', 'timeFrame': 'Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose', 'description': 'Pharmacokinetic (PK) parameter estimates from evacetrapib concentrations following single dose and daily dose of 130 mg evacetrapib.'}, {'measure': 'PK: Maximum Concentration (Cmax) of Evacetrapib', 'timeFrame': 'Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose', 'description': 'Pharmacokinetic parameter estimates from evacetrapib following single dose and daily doses of 130 mg.'}, {'measure': 'PK: Time to Maximum Concentration (Tmax) of Evacetrapib', 'timeFrame': 'Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.', 'description': 'Pharmacokinetic parameter estimates of evacetrapib following single and daily doses of 130 mg evacetrapib.'}, {'measure': 'PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin', 'timeFrame': 'Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose', 'description': 'Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily AUC (0-24).'}, {'measure': 'PK: Cmax of Evacetrapib Alone and With Simvastatin or Atorvastatin', 'timeFrame': 'Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.', 'description': 'Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily.'}, {'measure': 'PK: Tmax of Evacetrapib Alone and With Simvastatin or Atorvastatin', 'timeFrame': 'Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.', 'description': 'Pharmacokinetic parameter estimates of Tmax of evacetrapib following 130 mg daily dose alone or with 40 mg Simvastatin or 20 mg Atorvastatin. Tmax of simvastatin and atorvastatin.'}], 'secondaryOutcomes': [{'measure': 'Effect of Evacetrapib Single and Multiple Doses on High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)', 'timeFrame': 'Single Dose Day 2 and Multiple Dose Day 22'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate how the body responds to evacetrapib and to evaluate the safety and the effect of evacetrapib, alone and in combination with selected statins, in healthy Chinese participants. The study has 2 parts. Part one will last up to 4 weeks and part two will last up to 5 weeks, not including screening. Participants may only enroll in one part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are native Chinese and living in China.\n* Are overtly healthy males or females as determined by medical history and physical examination.\n* Female participants:\n\n * Women not of child-bearing potential\n * Women of child-bearing potential must correctly use 2 forms of reliable contraception to avoid getting pregnant during the study and for 3 months after the study is completed.\n* Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m\\^2)\n* BP and pulse rate at both supine and standing positions of approximately a systolic BP ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg\n* Participants with untreated hypercholesterolemia may be included if not on an herbal or other traditional Chinese medicines (TCM)\n* Have no known liver disease\n* Have given written informed consent\n\nExclusion Criteria:\n\n* Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Have known allergies to evacetrapib, simvastatin, or atorvastatin, related compounds or any components of the formulation\n* Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.\n* Have a history within the last year or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic 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* Show evidence of significant active neuropsychiatric disease.\n* Regularly use known drugs of abuse\n* Are women with a positive pregnancy test or women who are lactating.\n* Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements) or TCM 14 days prior to the first dose and during the study.\n\n * Hormonal contraceptives are permitted.\n* Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1), or of any other transporters involved in simvastatin or atorvastatin disposition, or of any drugs or substances that are known to be strong inducers or inhibitors of cytochrome P450 3A (CYP3A) within 30 days prior to the first dose and throughout the study.\n* Donated blood of \\>400 mL within the last month.\n* Drink alcoholic beverages with intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing until discharge from the clinical research unit (CRU) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).\n* Are unwilling to comply with the dietary requirements/restrictions during the study'}, 'identificationModule': {'nctId': 'NCT02156492', 'briefTitle': 'A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Study of Evacetrapib With Selected Statins in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': '14467'}, 'secondaryIdInfos': [{'id': 'I1V-MC-EIAM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evacetrapib Single', 'description': 'Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.', 'interventionNames': ['Drug: Evacetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Evacetrapib Multiple', 'description': 'Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib for 14 days.', 'interventionNames': ['Drug: Evacetrapib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin', 'description': 'Part 2, Cohorts B, Participants will receive simvastatin orally, once daily on Days 1 - 4.', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Evacetrapib and Simvastatin', 'description': 'Part 2, Cohorts B, Participants will receive evacetrapib orally once daily on Days 5 - 14 and simvastatin orally, once daily on Days 15 - 22.', 'interventionNames': ['Drug: Evacetrapib', 'Drug: Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'Part 2, Cohorts C, Participants will receive atorvastatin orally, once daily on Days 1 - 4.', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Evacetrapib and Atorvastatin', 'description': 'Part 2, Cohorts C, Participants will receive evacetrapib orally once daily on Days 5 - 14 and atorvastatin orally, once daily on Days 15 - 22.', 'interventionNames': ['Drug: Evacetrapib', 'Drug: Atorvastatin']}], 'interventions': [{'name': 'Evacetrapib', 'type': 'DRUG', 'otherNames': ['LY2484595'], 'description': 'Administered orally.', 'armGroupLabels': ['Evacetrapib Multiple', 'Evacetrapib Single', 'Evacetrapib and Atorvastatin', 'Evacetrapib and Simvastatin']}, {'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Evacetrapib and Simvastatin', 'Simvastatin']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Atorvastatin', 'Evacetrapib and Atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'country': 'China', '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': 39.9075, 'lon': 116.39723}}], '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'}}}}