Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT04991766
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2021-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719756', 'term': 'Imlunestrant'}]}}, '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': 'Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16', 'description': 'All enrolled participants who received at least 1 dose of LY3484356 or \\[14C\\]-LY3484356, whether or not they completed all protocol requirements.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 2: LY3484356 + [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an IV infusion on day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '101.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose', 'description': 'The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) \\* 100.', 'unitOfMeasure': 'percentage of the total radioactive dose', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.278', 'groupId': 'OG000', 'lowerLimit': '0.109', 'upperLimit': '0.497'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose', 'description': 'The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) \\* 100.', 'unitOfMeasure': 'percentage of the total radioactive dose', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'PRIMARY', 'title': 'Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LY3484356 + [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg) as an IV infusion on day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as "F %= \\[AUC (0-∞), LY3484356\\] × \\[Dose, \\[14C\\]-LY3484356\\] / \\[AUC (0-∞), \\[14C\\]-LY3484356\\] × \\[Dose, LY3484356\\] ×100%\'\' Higher percent indicates better absorption of drug into the body.', 'unitOfMeasure': 'percent absolute bioavailability', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of LY3484356 + \\[¹⁴C\\]-LY3484356 and have evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 1: PK: Total Radioactivity Recovered in Urine, Feces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'title': 'Urine Radioactivity', 'categories': [{'measurements': [{'value': '0.278', 'groupId': 'OG000', 'lowerLimit': '0.109', 'upperLimit': '0.497'}]}]}, {'title': 'Fecal Radioactivity', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '101.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose', 'description': 'Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine/Feces=\\[(percentage of radioactivity in peak)/100\\]\\*(percentage of dose in sample).', 'unitOfMeasure': 'percentage of recovered radioactivity', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 1: Total Radioactivity Recovered in Expired Air', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'title': '8 hours postdose', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': '24 hours postdose', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'predose, 8, and 24 hours postdose', 'description': 'Radioactivity is expressed in becquerels (Bq), the International System of Unit (SI) representing one nuclear disintegration per second. For practical measurement, total radioactivity recovered in expired air is reported in disintegrations per minute (dpm). The conversion factor is: 1 Bq = 60 dpm.', 'unitOfMeasure': 'disintegrations per minute', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Urine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Feces', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose', 'description': 'Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency.', 'unitOfMeasure': 'number of metabolites', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3130', 'spread': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: AUC \\[0-∞\\] of LY3484356 in Plasma.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '17900', 'spread': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: AUC \\[0-∞\\] of Plasma Total Radioactivity.\n\nTotal radioactivity is reported as nanogram\\* hours equivalents per milliliter (ng\\*h Eq/mL).', 'unitOfMeasure': 'ng*h Eq/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'spread': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: Cmax for LY3484356 in plasma.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '537', 'spread': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL).', 'unitOfMeasure': 'ng Eq/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of \\[¹⁴C\\]-LY3484356 and had evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LY3484356 + [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg) as an IV infusion on day 1.'}], 'classes': [{'title': 'Plasma [14C]-LY3484356', 'categories': [{'measurements': [{'value': '1.95', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': 'Plasma LY3484356', 'categories': [{'measurements': [{'value': '1810', 'spread': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: AUC \\[0-∞\\] of Total Radioactivity.\n\nTotal radioactivity is reported as hours\\*nanogram equivalents per milliliter (h\\*ng Eq/mL).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of LY3484356 or \\[¹⁴C\\]-LY3484356 and have evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LY3484356 + [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg) as an IV infusion on day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.44', 'spread': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: AUC \\[0-∞\\] of Total Radioactivity in Plasma.', 'unitOfMeasure': 'ng*h Eq/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of LY3484356 or \\[¹⁴C\\]-LY3484356 and have evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LY3484356 + [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg) as an IV infusion on day 1.'}], 'classes': [{'title': 'Plasma [14C]-LY3484356', 'categories': [{'measurements': [{'value': '0.575', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': 'Plasma LY3484356', 'categories': [{'measurements': [{'value': '33.1', 'spread': '59', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: Cmax of LY3484356 and \\[¹⁴C\\]-LY3484356 in plasma.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of LY3484356 or \\[¹⁴C\\]-LY3484356 and have evaluable PK data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LY3484356 + [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg) as an IV infusion on day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.857', 'spread': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: Cmax of total radioactivity in plasma.', 'unitOfMeasure': 'ng Eq/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of LY3484356 or \\[¹⁴C\\]-LY3484356 and have evaluable PK data for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 milligram (mg) Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}, {'id': 'FG001', 'title': 'Part 2: LY3484356 + [¹⁴C] LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 microgram (μg) \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This is a two-part study. Participants in Part 1 did not participate in Part 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: [¹⁴C]-LY3484356', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.'}, {'id': 'BG001', 'title': 'Part 2: LY3484356 + [¹⁴C] LY3484356', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an IV infusion on day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants who received at least 1 dose of study drug (LY3484356 or \\[¹⁴C\\]-LY3484356).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-05', 'size': 4235199, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-02T11:11', 'hasProtocol': True}, {'date': '2021-07-21', 'size': 2015592, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-02T11:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11-15', 'completionDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2021-08-02', 'resultsFirstSubmitDate': '2025-10-22', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered', 'timeFrame': 'Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose', 'description': 'The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) \\* 100.'}, {'measure': 'Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered', 'timeFrame': 'Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose', 'description': 'The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) \\* 100.'}, {'measure': 'Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as "F %= \\[AUC (0-∞), LY3484356\\] × \\[Dose, \\[14C\\]-LY3484356\\] / \\[AUC (0-∞), \\[14C\\]-LY3484356\\] × \\[Dose, LY3484356\\] ×100%\'\' Higher percent indicates better absorption of drug into the body.'}], 'secondaryOutcomes': [{'measure': 'Part 1: PK: Total Radioactivity Recovered in Urine, Feces', 'timeFrame': 'Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose', 'description': 'Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine/Feces=\\[(percentage of radioactivity in peak)/100\\]\\*(percentage of dose in sample).'}, {'measure': 'Part 1: Total Radioactivity Recovered in Expired Air', 'timeFrame': 'predose, 8, and 24 hours postdose', 'description': 'Radioactivity is expressed in becquerels (Bq), the International System of Unit (SI) representing one nuclear disintegration per second. For practical measurement, total radioactivity recovered in expired air is reported in disintegrations per minute (dpm). The conversion factor is: 1 Bq = 60 dpm.'}, {'measure': 'Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces', 'timeFrame': 'Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose', 'description': 'Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency.'}, {'measure': 'Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma', 'timeFrame': 'Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: AUC \\[0-∞\\] of LY3484356 in Plasma.'}, {'measure': 'Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma', 'timeFrame': 'Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: AUC \\[0-∞\\] of Plasma Total Radioactivity.\n\nTotal radioactivity is reported as nanogram\\* hours equivalents per milliliter (ng\\*h Eq/mL).'}, {'measure': 'Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: Cmax for LY3484356 in plasma.'}, {'measure': 'Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose', 'description': 'PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL).'}, {'measure': 'Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: AUC \\[0-∞\\] of Total Radioactivity.\n\nTotal radioactivity is reported as hours\\*nanogram equivalents per milliliter (h\\*ng Eq/mL).'}, {'measure': 'Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: AUC \\[0-∞\\] of Total Radioactivity in Plasma.'}, {'measure': 'Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: Cmax of LY3484356 and \\[¹⁴C\\]-LY3484356 in plasma.'}, {'measure': 'Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma', 'timeFrame': 'Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose', 'description': 'PK: Cmax of total radioactivity in plasma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolism', 'Absolute Bioavailability', 'Disposition'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal.\n* Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders\n* Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies\n* Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy'}, 'identificationModule': {'nctId': 'NCT04991766', 'briefTitle': 'A Study of [¹⁴C]-LY3484356 in Healthy Female Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential', 'orgStudyIdInfo': {'id': '18205'}, 'secondaryIdInfos': [{'id': 'J2J-MC-JZLE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[¹⁴C]-LY3484356 (Part 1)', 'description': 'Participants received a single oral dose of 400 mg Carbon 14 labelled \\[¹⁴C\\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.', 'interventionNames': ['Drug: [¹⁴C]-LY3484356']}, {'type': 'EXPERIMENTAL', 'label': 'LY3484356 + [¹⁴C]-LY3484356 (Part 2)', 'description': 'Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 microgram (μg) \\[¹⁴C\\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1.', 'interventionNames': ['Drug: LY3484356', 'Drug: [¹⁴C]-LY3484356 (IV)']}], 'interventions': [{'name': '[¹⁴C]-LY3484356', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['[¹⁴C]-LY3484356 (Part 1)']}, {'name': 'LY3484356', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3484356 + [¹⁴C]-LY3484356 (Part 2)']}, {'name': '[¹⁴C]-LY3484356 (IV)', 'type': 'DRUG', 'description': 'Administered IV.', 'armGroupLabels': ['LY3484356 + [¹⁴C]-LY3484356 (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'LabCorp CRU, Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}}}}