Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-04-17 @ 6:31 PM
Study NCT ID:
NCT05134350
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2021-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723100', 'term': 'pirtobrutinib'}, {'id': 'D009853', 'term': 'Omeprazole'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '08005455979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to Day 32', 'description': 'All participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment C: 40 mg Omeprazole (Fasted)', 'description': 'All participants who received single oral dose of 40 mg Omeprazole (Fasted) on Day 15 to 17.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '55100', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '51900', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '59900', 'spread': '15.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose', 'description': 'PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method.', 'unitOfMeasure': 'hour*nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '89400', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '85100', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '99600', 'spread': '17.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: AUC(0-t) of LOXO-305 is reported. AUC(0-t) was calculated by linear trapezoidal method.', 'unitOfMeasure': 'hour*nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-Inf]) of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '90200', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '86100', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '101000', 'spread': '16.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: AUC(0-inf) of LOXO-305 is reported. AUC(0-inf) was calculated using the formula: AUC(0-inf) = AUC(0-t) + Ct/λZ; where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant.', 'unitOfMeasure': 'hour*nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Percentage Extrapolation for AUC0-Inf (%AUCextrap) of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.911', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '42.6', 'groupId': 'OG001'}, {'value': '0.893', 'spread': '34.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: %AUCextrap of LOXO-305 is reported.', 'unitOfMeasure': 'percentage of extrapolation', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '5450', 'spread': '31.7', 'groupId': 'OG000'}, {'value': '4340', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '5490', 'spread': '16.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: Cmax of LOXO-305 is reported.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Time to Maximum Observed Plasma Concentration (Tmax) of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.25', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: tmax of LOXO-305 is reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Apparent Terminal Elimination Half-life (t½) of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '5.75', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '2.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: t½ of LOXO-305 is reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Apparent Systemic Clearance (CL/F) of LOXO-305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: 200 mg LOXO-305 (Fasted)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2).'}, {'id': 'OG001', 'title': 'Treatment B: 200 mg LOXO-305 (Fed)', 'description': 'All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1).'}, {'id': 'OG002', 'title': 'Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted)', 'description': 'All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '1.99', 'spread': '16.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: CL/F of LOXO-305 is reported.', 'unitOfMeasure': 'Liter per Hours (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of LOXO-305 and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence 1: ABC', 'description': '* Period 1: Single oral dose of 200 milligram (mg) LOXO-305 (Fasted state) on Day 1 (Treatment A)\n* Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B)\n* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)\n\nA washout period of 7 days was maintained between each treatment period.'}, {'id': 'FG001', 'title': 'Treatment Sequence 2: BAC', 'description': '* Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B)\n* Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A)\n* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)\n\nA washout period of 7 days was maintained between each treatment period.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were randomized to 2 treatment sequences (ABC and BAC), with each sequence having 3 periods where participants were crossed over between the periods in each sequence. A washout period of 7 days was maintained between each treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence 1: ABC', 'description': '* Period 1: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 1 (Treatment A)\n* Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B)\n* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)\n\nA washout period of 7 days was maintained between each treatment period.'}, {'id': 'BG001', 'title': 'Treatment Sequence 2: BAC', 'description': '* Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B)\n* Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A)\n* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)\n\nA washout period of 7 days was maintained between each treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '10.66', 'groupId': 'BG000'}, {'value': '35.2', 'spread': '4.87', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '8.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-29', 'size': 2803382, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-26T03:30', 'hasProtocol': True}, {'date': '2020-05-21', 'size': 806691, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-25T01:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2021-10-22', 'resultsFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-19', 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose', 'description': 'PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method.'}, {'measure': 'PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: AUC(0-t) of LOXO-305 is reported. AUC(0-t) was calculated by linear trapezoidal method.'}, {'measure': 'PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-Inf]) of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: AUC(0-inf) of LOXO-305 is reported. AUC(0-inf) was calculated using the formula: AUC(0-inf) = AUC(0-t) + Ct/λZ; where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant.'}, {'measure': 'PK: Percentage Extrapolation for AUC0-Inf (%AUCextrap) of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: %AUCextrap of LOXO-305 is reported.'}, {'measure': 'PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: Cmax of LOXO-305 is reported.'}, {'measure': 'PK: Time to Maximum Observed Plasma Concentration (Tmax) of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: tmax of LOXO-305 is reported.'}, {'measure': 'PK: Apparent Terminal Elimination Half-life (t½) of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: t½ of LOXO-305 is reported.'}, {'measure': 'PK: Apparent Systemic Clearance (CL/F) of LOXO-305', 'timeFrame': 'Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post LOXO-305 dose', 'description': 'PK: CL/F of LOXO-305 is reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females of non-childbearing potential.\n* Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).\n* Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).\n* Able to comply with all study procedures, including the 25-night stay at the Clinical Research Unit and follow-up phone call.\n\nExclusion Criteria:\n\n* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:\n\n * liver disease\n * pancreatitis\n * peptic ulcer disease\n * intestinal malabsorption\n * gastric reduction surgery\n * history or presence of clinically significant cardiovascular disease.\n* Participants with out-of-range, at-rest vital signs.\n* Abnormal laboratory values determined to be clinically significant by the Investigator (or designee), and Sponsor.\n* Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.\n* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).\n* Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) through the end of the trial.\n* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.\n* Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.\n* Receipt of blood products within 2 months prior to Check-in (Day -1).\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), GI, neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).'}, 'identificationModule': {'nctId': 'NCT05134350', 'briefTitle': 'Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Open Label, Randomized, 2-Way Crossover, 3-Period Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of LOXO-305 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'LOXO-BTK-20014'}, 'secondaryIdInfos': [{'id': 'J2N-OX-JZNH', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence 1: ABC', 'description': '* Period 1: Single oral dose of 200 milligram (mg) LOXO-305 (Fasted state) on Day 1 (Treatment A)\n* Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B)\n* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)\n\nA washout period of 7 days was maintained between each treatment period.', 'interventionNames': ['Drug: LOXO-305', 'Drug: Omeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence 2: BAC', 'description': '* Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B)\n* Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A)\n* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)\n\nA washout period of 7 days was maintained between each treatment period.', 'interventionNames': ['Drug: LOXO-305', 'Drug: Omeprazole']}], 'interventions': [{'name': 'LOXO-305', 'type': 'DRUG', 'description': 'LOXO-305 orally.', 'armGroupLabels': ['Treatment Sequence 1: ABC', 'Treatment Sequence 2: BAC']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Omeprazole Orally.', 'armGroupLabels': ['Treatment Sequence 1: ABC', 'Treatment Sequence 2: BAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Renée Ward, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Loxo Oncology, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loxo Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}