Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT05444556
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2022-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Imlunestrant (LY3484356) in Female Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719756', 'term': 'Imlunestrant'}, {'id': 'C072379', 'term': 'repaglinide'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D003915', 'term': 'Dextromethorphan'}, {'id': 'D011802', 'term': 'Quinidine'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002930', 'term': 'Cinchona Alkaloids'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days', 'description': 'All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen', 'eventGroups': [{'id': 'EG000', 'title': '0.5 mg Repaglinide: Cohort 1', 'description': 'Participants received a single oral dose of 0.5 mg repaglinide administered alone on Day 1.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 2, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '800 mg Imlunestrant + 0.5 mg Repaglinide: Cohort 1', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally on Day 3.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '400 mg Imlunestrant (Day 1): Cohort 3', 'description': 'Participants received a single oral dose of 400 mg imlunestrant administered alone on Day 1.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 9, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '200 mg Quinidine BID (Days 15 to 17): Cohort 3', 'description': 'Participants received twice-daily oral doses of 200 mg quinidine, administered alone from days 15 to 17.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 3, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '400 mg Imlunestrant + 200 mg Quinidine BID (Day 18): Cohort 3', 'description': 'Participants received a single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen) on day 18.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '200 mg Quinidine BID (Days 19 to 24): Cohort 3', 'description': 'Participants received BID oral doses of 200 mg quinidine, administered alone from Days 19 to 24.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': '10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4', 'description': 'Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': '400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4', 'description': 'Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mg Repaglinide', 'description': 'Participants received a single oral dose of 0.5 mg repaglinide administered alone on Day 1.'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 0.5 mg Repaglinide', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '31', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose', 'description': 'PK: AUC\\[0-∞\\] of Repaglinide', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mg Repaglinide', 'description': 'Participants received a single oral dose of 0.5 mg repaglinide administered alone on Day 1.'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 0.5 mg Repaglinide', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '38', 'groupId': 'OG000'}, {'value': '9.84', 'spread': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose', 'description': 'PK: Cmax of Repaglinide', 'unitOfMeasure': 'nanogram per millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: AUC[0-∞] of Omeprazole (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '703', 'spread': '77', 'groupId': 'OG000'}, {'value': '825', 'spread': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: AUC\\[0-∞\\] of Omeprazole', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Omeprazole (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '316', 'spread': '73', 'groupId': 'OG000'}, {'value': '405', 'spread': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: Cmax of Omeprazole', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: AUC[0-∞] of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '571', 'spread': '26', 'groupId': 'OG000'}, {'value': '592', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': '5-hydroxyomeprazole is a major metabolite of omeprazole.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'spread': '52', 'groupId': 'OG000'}, {'value': '230', 'spread': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': '5-hydroxyomeprazole is a major metabolite of omeprazole.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: AUC[0-∞] of Dextromethorphan (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '127', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '111', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: AUC\\[0-∞\\] of Dextromethorphan', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Dextromethorphan (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.864', 'spread': '124', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '124', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: Cmax of Dextromethorphan', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUC[0-tlast]) of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '62', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'Dextrorphan is a major metabolite of Dextromethorphan.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1'}, {'id': 'OG001', 'title': '800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan', 'description': 'Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'spread': '50', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'Dextrorphan is a major metabolite of Dextromethorphan.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: AUC[0-∞] of Imlunestrant (Cohort 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg Imlunestrant (Day 1)', 'description': 'Participants received a single oral dose of 400 mg imlunestrant administered alone on Day 1.'}, {'id': 'OG001', 'title': '400 mg Imlunestrant + 200 mg Quinidine BID (Day 18)', 'description': 'Participants received a single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen) on day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '1970', 'spread': '66', 'groupId': 'OG000'}, {'value': '1870', 'spread': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose', 'description': 'PK: AUC\\[0-∞\\] of Imlunestrant', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All cohort 3 participants who received at least one dose of imlunestrant and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Imlunestrant (Cohort 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg Imlunestrant (Day 1)', 'description': 'Participants received a single oral dose of 400 mg imlunestrant administered alone on Day 1.'}, {'id': 'OG001', 'title': '400 mg Imlunestrant + 200 mg Quinidine BID (Day 18)', 'description': 'Participants received a single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen) on day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '82', 'groupId': 'OG000'}, {'value': '54.3', 'spread': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose', 'description': 'PK: Cmax of Imlunestrant', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All cohort 3 participants who received at least one dose of imlunestrant and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: AUC[0-∞] of Rosuvastatin (Cohort 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.'}, {'id': 'OG001', 'title': '400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '47', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: AUC\\[0-∞\\] of Rosuvastatin', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All cohort 4 participants who received at least one dose of rosuvastatin and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Rosuvastatin (Cohort 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.'}, {'id': 'OG001', 'title': '400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'spread': '53', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: Cmax of Rosuvastatin', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All cohort 4 participants who received at least one dose of rosuvastatin and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: AUC[0-∞] of Digoxin (Cohort 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.'}, {'id': 'OG001', 'title': '400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '23', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: AUC\\[0-∞\\] of Digoxin', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All cohort 4 participants who received at least one dose of digoxin and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'PK: Cmax of Digoxin (Cohort 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.'}, {'id': 'OG001', 'title': '400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin', 'description': 'Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '39', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: Cmax of Digoxin', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All cohort 4 participants who received at least one dose of digoxin and had evaluable PK data for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imlunestrant + Repaglinide (Cohort 1)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 0.5 mg repaglinide administered alone.\n\nDay 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.'}, {'id': 'FG001', 'title': 'Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning.\n\nDay 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.'}, {'id': 'FG002', 'title': 'Imlunestrant + Quinidine (Cohort 3)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 400 mg imlunestrant, administered in the morning.\n\nDays 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone.\n\nDay 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).'}, {'id': 'FG003', 'title': 'Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning.\n\nDay 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'comment': 'One participant did not receive the second dose of imlunestrant in combination with quinidine on Day 18, or the subsequent doses of quinidine alone on Days 19 through 24', 'groupId': 'FG002', 'numSubjects': '32'}, {'comment': 'One participant did not receive the planned dose of imlunestrant in combination with rosuvastatin and digoxin on Day 10.', 'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Imlunestrant + Repaglinide (Cohort 1)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 0.5 mg repaglinide administered alone.\n\nDay 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.'}, {'id': 'BG001', 'title': 'Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning.\n\nDay 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.'}, {'id': 'BG002', 'title': 'Imlunestrant + Quinidine (Cohort 3)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 400 mg imlunestrant, administered in the morning.\n\nDays 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone.\n\nDay 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).'}, {'id': 'BG003', 'title': 'Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning.\n\nDay 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '52.6', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '7.1', 'groupId': 'BG003'}, {'value': '54.1', 'spread': '7.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-26', 'size': 1435788, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-13T12:50', 'hasProtocol': True}, {'date': '2023-03-28', 'size': 493704, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-13T12:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11-15', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2022-06-30', 'resultsFirstSubmitDate': '2025-10-22', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-26', 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1)', 'timeFrame': 'Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose', 'description': 'PK: AUC\\[0-∞\\] of Repaglinide'}, {'measure': 'PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1)', 'timeFrame': 'Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose', 'description': 'PK: Cmax of Repaglinide'}, {'measure': 'PK: AUC[0-∞] of Omeprazole (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: AUC\\[0-∞\\] of Omeprazole'}, {'measure': 'PK: Cmax of Omeprazole (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: Cmax of Omeprazole'}, {'measure': 'PK: AUC[0-∞] of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': '5-hydroxyomeprazole is a major metabolite of omeprazole.'}, {'measure': 'PK: Cmax of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': '5-hydroxyomeprazole is a major metabolite of omeprazole.'}, {'measure': 'PK: AUC[0-∞] of Dextromethorphan (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: AUC\\[0-∞\\] of Dextromethorphan'}, {'measure': 'PK: Cmax of Dextromethorphan (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'PK: Cmax of Dextromethorphan'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUC[0-tlast]) of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'Dextrorphan is a major metabolite of Dextromethorphan.'}, {'measure': 'PK: Cmax of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose', 'description': 'Dextrorphan is a major metabolite of Dextromethorphan.'}, {'measure': 'PK: AUC[0-∞] of Imlunestrant (Cohort 3)', 'timeFrame': 'Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose', 'description': 'PK: AUC\\[0-∞\\] of Imlunestrant'}, {'measure': 'PK: Cmax of Imlunestrant (Cohort 3)', 'timeFrame': 'Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose', 'description': 'PK: Cmax of Imlunestrant'}, {'measure': 'PK: AUC[0-∞] of Rosuvastatin (Cohort 4)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: AUC\\[0-∞\\] of Rosuvastatin'}, {'measure': 'PK: Cmax of Rosuvastatin (Cohort 4)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: Cmax of Rosuvastatin'}, {'measure': 'PK: AUC[0-∞] of Digoxin (Cohort 4)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: AUC\\[0-∞\\] of Digoxin'}, {'measure': 'PK: Cmax of Digoxin (Cohort 4)', 'timeFrame': 'Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose', 'description': 'PK: Cmax of Digoxin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effect of imlunestrant on repaglinide, omeprazole and dextromethorphan, and rosuvastatin and digoxin. The study will also investigate the effect of quinidine on imlunestrant in female healthy participants of non-childbearing potential. The safety and tolerability of imlunestrant will be investigated in female healthy participants of non-childbearing potential. The study will last approximately up to 32 days for each participant excluding the screening period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical assessment\n* Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)\n* Female participants of non childbearing potential.\n\nExclusion Criteria:\n\n* Have known allergies to imlunestrant, related compounds or any components of the formulation, repaglinide, omeprazole, dextromethorphan, quinidine, rosuvastatin, or digoxin, as appropriate, or history of significant atopy.\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator\n* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing\n* Use or intend to use any prescription medications/products within 14 days prior to first dose until completion of the follow-up visit, unless deemed acceptable by the investigator (or designee), including but not limited to medications that inhibit or induce cytochrome P450 (CYP) 2C8, CYP2C19, CYP2D6, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP)."}, 'identificationModule': {'nctId': 'NCT05444556', 'briefTitle': 'A Study of Imlunestrant (LY3484356) in Female Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential', 'orgStudyIdInfo': {'id': '18413'}, 'secondaryIdInfos': [{'id': 'J2J-MC-JZLI', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imlunestrant + Repaglinide (Cohort 1)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 0.5 mg repaglinide administered alone. Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.', 'interventionNames': ['Drug: Imlunestrant', 'Drug: Repaglinide']}, {'type': 'EXPERIMENTAL', 'label': 'mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning.\n\nDay 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.', 'interventionNames': ['Drug: Imlunestrant', 'Drug: Omeprazole', 'Drug: Dextromethorphan']}, {'type': 'EXPERIMENTAL', 'label': 'Imlunestrant + Quinidine (Cohort 3)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 400 mg imlunestrant, administered in the morning. Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone.\n\nDay 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).', 'interventionNames': ['Drug: Imlunestrant', 'Drug: Quinidine']}, {'type': 'EXPERIMENTAL', 'label': 'Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)', 'description': 'Participants received:\n\nDay 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning.\n\nDay 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.', 'interventionNames': ['Drug: Imlunestrant', 'Drug: Rosuvastatin', 'Drug: Digoxin']}], 'interventions': [{'name': 'Imlunestrant', 'type': 'DRUG', 'otherNames': ['LY3484356'], 'description': 'Administered orally.', 'armGroupLabels': ['Imlunestrant + Quinidine (Cohort 3)', 'Imlunestrant + Repaglinide (Cohort 1)', 'Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)', 'mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)']}, {'name': 'Repaglinide', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Imlunestrant + Repaglinide (Cohort 1)']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)']}, {'name': 'Dextromethorphan', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)']}, {'name': 'Quinidine', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Imlunestrant + Quinidine (Cohort 3)']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)']}, {'name': 'Digoxin', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Altasciences Clinical Los Angeles, Inc', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'zip': '33143-4875', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Early Phase Services', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}