Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-24 @ 8:11 PM
Study NCT ID:
NCT06494761
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2024-07-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'C072379', 'term': 'repaglinide'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D001562', 'term': 'Benzimidazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '018002430127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'AE collection timeframe: Repa (R1) & Zonger+Repa (T1, T3): up to 24h; Mida+Ome (R2) & Zonger+Mida+Ome (T2, T4): up to 48h; Zonger: up to 14d post-dose. All-cause mortality: Up to 50 days', 'description': 'Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Repaglinide (Reference Treatment 1)', 'description': 'Participants received a single 0.5 mg repaglinide tablet on Day 1 of Period 1, after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Midazolam + Omeprazole (Reference Treatment 2)', 'description': 'Participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 of Period 1, following an overnight fast of at least 10 hours.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zongertinib +Repaglinide (Test Treatment 1)', 'description': 'Participants received 120 mg zongertinib (two 60 mg tablets) and a single 0.5 mg repaglinide tablet on Day 1 of Period 2, after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Zongertinib +Midazolam +Omeprazole (Test Treatment 2)', 'description': 'Participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Zongertinib', 'description': 'Participants received 120 mg zongertinib daily (as two 60 mg tablets) from Day 1 to Day 15 of Period 2.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 9, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Zongertinib +Repaglinide (Test Treatment 3)', 'description': 'Participants received 0.5 mg repaglinide coadministered with zongertinib on Day 14 of Period 2, after 13 days of zongertinib pretreatment and an overnight fast.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Zongertinib + Midazolam + Omeprazole (Test Treatment 4)', 'description': 'Participants received 1 mg midazolam and 20 mg omeprazole coadministered with zongertinib on Day 15 of Period 2, after 14 days of zongertinib pretreatment and an overnight fast.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repaglinide Alone (Reference Treatment 1)', 'description': 'In the reference treatment period (Period 1), participants received a single oral dose of 0.5 mg repaglinide on Day 1 following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Repaglinide with a single dose of zongertinib (Test Treatment 1)', 'description': 'In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Repaglinide after multiple doses of zongertinib (Test Treatment 3)', 'description': 'In the test treatment period (period 2), participants received 120 mg zongertinib (two 60 mg tablets) daily for 13 consecutive days. On Day 14, after 13 days of zongertinib administration, a single dose of 0.5 mg repaglinide tablet was coadministered with 120 mg zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '28100', 'spread': '58.0', 'groupId': 'OG000'}, {'value': '31200', 'spread': '49.2', 'groupId': 'OG001'}, {'value': '37300', 'spread': '48.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.98', 'ciLowerLimit': '96.90', 'ciUpperLimit': '127.10', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 22.1', 'groupDescription': 'The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered with a single dose of zongertinib (Test Treatment 1) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '130.10', 'ciLowerLimit': '110.35', 'ciUpperLimit': '153.39', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 25.2', 'groupDescription': 'The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered after multiple doses of zongertinib (Test Treatment 3) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported.\n\nPeriod 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.', 'unitOfMeasure': 'Hours × picomoles per liter (h*pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment 3 Arm.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam + Omeprazole (Reference Treatment 2)', 'description': 'In the reference treatment period (Period 1), participants received a single oral dose of 1 mg Midazolam (0.5 mL oral solution) on Day 2, coadministered with a 20 mg Omeprazole tablet following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2)', 'description': 'In the test treatment period (Period 2), participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)', 'description': 'In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '41400', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '44200', 'spread': '37.3', 'groupId': 'OG001'}, {'value': '43400', 'spread': '27.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.80', 'ciLowerLimit': '98.57', 'ciUpperLimit': '117.90', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 13.5', 'groupDescription': 'The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.62', 'ciLowerLimit': '95.41', 'ciUpperLimit': '116.93', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 15.4', 'groupDescription': 'The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.', 'unitOfMeasure': 'Hours × picomoles per liter (h*pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment Arm 2 and 3.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam + Omeprazole (Reference Treatment 2)', 'description': 'In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Midazolam + Omeprazole after a single dose of zongertinib (Test Treatments 2)', 'description': 'In the test treatment period (Period 2), participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)', 'description': 'In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '378', 'spread': '69.7', 'groupId': 'OG000'}, {'value': '359', 'spread': '66.9', 'groupId': 'OG001'}, {'value': '296', 'spread': '60.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.55', 'ciLowerLimit': '75.96', 'ciUpperLimit': '122.72', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 24.5', 'groupDescription': 'The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.75', 'ciLowerLimit': '61.86', 'ciUpperLimit': '130.20', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 39.6', 'groupDescription': 'The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of omeprazole in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.', 'unitOfMeasure': 'hour * nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results were reported.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of Repaglinide in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repaglinide Alone (Reference Treatment 1)', 'description': 'In the reference treatment period (Period 1), participants received a single oral dose of 0.5 mg repaglinide on Day 1 following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Repaglinide with a single dose of zongertinib (Test Treatments 1)', 'description': 'In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Repaglinide after multiple doses of zongertinib (Test Treatment 3)', 'description': 'In the test treatment period (period 2), participants received 120 mg zongertinib (two 60 mg tablets) daily for 13 consecutive days. On Day 14, after 13 days of zongertinib administration, a single dose of 0.5 mg repaglinide tablet was coadministered with 120 mg zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '20200', 'spread': '52.6', 'groupId': 'OG000'}, {'value': '23600', 'spread': '40.9', 'groupId': 'OG001'}, {'value': '29700', 'spread': '36.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '117.07', 'ciLowerLimit': '105.56', 'ciUpperLimit': '129.84', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 16.8', 'groupDescription': 'The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered with a single dose of zongertinib (Test Treatment 1) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '144.36', 'ciLowerLimit': '123.53', 'ciUpperLimit': '168.71', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 23.9', 'groupDescription': 'The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered after multiple doses of zongertinib (Test Treatment 3) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The maximum measured concentration of repaglinide in plasma is reported.\n\nPeriod 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.', 'unitOfMeasure': 'Picomoles per liter (pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment 3 Arm.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of Midazolam in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam + Omeprazole (Reference Treatment 2)', 'description': 'In the reference treatment period (Period 1), participants received a single oral dose of 1 mg Midazolam (0.5 mL oral solution) on Day 2, coadministered with a 20 mg Omeprazole tablet following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Midazolam + Omeprazole after a single dose of zongertinib (Test Treatments 2)', 'description': 'In the test treatment period (Period 2), participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)', 'description': 'In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '17700', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '19700', 'spread': '33.0', 'groupId': 'OG001'}, {'value': '20800', 'spread': '26.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.74', 'ciLowerLimit': '100.92', 'ciUpperLimit': '121.52', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 14.1', 'groupDescription': 'The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '117.19', 'ciLowerLimit': '108.30', 'ciUpperLimit': '126.81', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 11.9', 'groupDescription': 'The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The maximum measured concentration of midazolam in plasma is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.', 'unitOfMeasure': 'Picomoles per liter (pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment Arm 2 and 3.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of Omeprazole in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam + Omeprazole (Reference Treatment 2)', 'description': 'In the reference treatment period (Period 1), participants received 1 mg midazolam (0.5 mL oral solution) coadministered with a 20 mg omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Midazolam + Omeprazole after a single dose of zongertinib (Test Treatments 2)', 'description': 'In the test treatment period (Period 2), participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)', 'description': 'In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '165', 'spread': '91.7', 'groupId': 'OG000'}, {'value': '131', 'spread': '78.3', 'groupId': 'OG001'}, {'value': '101', 'spread': '79.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '79.39', 'ciLowerLimit': '49.90', 'ciUpperLimit': '126.30', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 77.6', 'groupDescription': 'The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '62.07', 'ciLowerLimit': '44.69', 'ciUpperLimit': '86.20', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 49.1', 'groupDescription': 'The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The maximum measured concentration of omeprazole in plasma is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results were reported.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Repaglinide Alone (Reference Treatment 1)', 'description': 'In the reference treatment period (Period 1), participants received a single oral dose of 0.5 mg repaglinide on Day 1 following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Repaglinide with a single dose of zongertinib (Test Treatments 1)', 'description': 'In the test treatment period (Period 2), Day 1, participants received a single 0.5 mg dose of repaglinide coadministered with a single 120 mg dose of zongertinib (two 60 mg tablets) following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Repaglinide after multiple doses of zongertinib (Test Treatment 3)', 'description': 'In the test treatment period (period 2), participants received 120 mg zongertinib (two 60 mg tablets) daily for 13 consecutive days. On Day 14, following 13 days of zongertinib administration, a single dose of 0.5 mg repaglinide tablet was coadministered with 120 mg zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '27700', 'spread': '58.3', 'groupId': 'OG000'}, {'value': '30700', 'spread': '50.5', 'groupId': 'OG001'}, {'value': '36700', 'spread': '48.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.86', 'ciLowerLimit': '96.58', 'ciUpperLimit': '127.24', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 22.5', 'groupDescription': 'The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered with a single dose of zongertinib (Test Treatment 1) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '129.80', 'ciLowerLimit': '109.70', 'ciUpperLimit': '153.59', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 25.8', 'groupDescription': 'The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered after multiple doses of zongertinib (Test Treatment 3) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data poin is reported.\n\nPeriod 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.', 'unitOfMeasure': 'Hours × picomoles per liter (h*pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment 3 Arm.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam + Omeprazole (Reference Treatment 2)', 'description': 'In the reference treatment period (Period 1), participants received a single oral dose of 1 mg Midazolam (0.5 mL oral solution) on Day 2, coadministered with a 20 mg Omeprazole tablet following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Midazolam + Omeprazole after a single dose of zongertinib (Test Treatments 2)', 'description': 'In the test treatment period (Period 2), participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)', 'description': 'In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '39600', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '42700', 'spread': '38.1', 'groupId': 'OG001'}, {'value': '41700', 'spread': '27.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.61', 'ciLowerLimit': '98.79', 'ciUpperLimit': '119.41', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 14.3', 'groupDescription': 'The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.03', 'ciLowerLimit': '95.49', 'ciUpperLimit': '117.73', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 15.9', 'groupDescription': 'The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.', 'unitOfMeasure': 'Hours × picomoles per liter (h*pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment Arm 2 and 3.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam + Omeprazole (Reference Treatment 2)', 'description': 'In the reference treatment period (Period 1), participants received 1 mg Midazolam (0.5 mL oral solution) coadministered with a 20 mg Omeprazole tablet on Day 2 following an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Midazolam + Omeprazole after a single dose of zongertinib (Test Treatments 2)', 'description': 'In the test treatment period (Period 2), participants received 120 mg zongertinib (two 60 mg tablets) on Day 1. On Day 2, after one day of zongertinib pretreatment, participants were administered 1 mg, midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4)', 'description': 'In the test treatment period (Period 2), participants received 120 mg Zongertinib daily (two 60 mg tablets) for 14 consecutive days. On Day 15, after 14 days of zongertinib treatment, participants received 1 mg midazolam, coadministered with 20 mg omeprazole, and zongertinib following an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '287', 'spread': '78.3', 'groupId': 'OG000'}, {'value': '304', 'spread': '72.8', 'groupId': 'OG001'}, {'value': '267', 'spread': '61.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.13', 'ciLowerLimit': '79.90', 'ciUpperLimit': '146.35', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 44.9', 'groupDescription': 'The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.81', 'ciLowerLimit': '75.01', 'ciUpperLimit': '127.53', 'estimateComment': 'Ratio calculated as test/reference\\*100. Intra-individual Geometric coefficient of variation \\[%\\] = 38.5', 'groupDescription': 'The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\\[T\\]-log\\[R\\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of omeprazole in plasma over the time interval from 0 to the last quantifiable data point is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with evaluable results were reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)', 'description': 'Reference (Repaglinide + Midazolam + Omeprazole)\n\nIn the reference treatment period (Period 1), participants received 0.5 mg repaglinide tablet (Day 1, after ≥10 h fast; Reference Treatment 1). On Day 2, they received 1 mg midazolam (0.5 mL oral solution) with 20 mg omeprazole tablet under the same fasting conditions (Reference Treatment 2).\n\nTest (Zongertinib + Repaglinide + Midazolam + Omeprazole)\n\nIn the test treatment period (Period 2), participants received multiple once-daily doses of 120 mg zongertinib from Day 1 to Day 15. A single 0.5 mg repaglinide tablet was co-administered on Day 1 (Test Treatment 1) and Day 14 (Test Treatment 3), and a single dose of the probe drug cocktail containing 1 mg midazolam (0.5 mL oral solution) and 20 mg omeprazole tablet was co-administered on Day 2 (Test Treatment 2) and Day 15 (Test Treatment 4).'}], 'periods': [{'title': 'Period 1 (Reference Period) (3 days)', 'milestones': [{'type': 'STARTED', 'comment': 'Started Trial Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'comment': 'Completed Trial Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (3 days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 2: (Test Period) (15 days)', 'milestones': [{'type': 'STARTED', 'comment': 'Started Trial Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'comment': 'Completed Trial Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This non-randomized, open-label, two-period, fixed-sequence trial evaluated the effect of multiple oral doses of zongertinib on the single-dose pharmacokinetics of midazolam, omeprazole, and repaglinide in healthy male subjects to assess potential drug-drug interactions.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)', 'description': 'Reference (Repaglinide + Midazolam + Omeprazole)\n\nIn the reference treatment period (Period 1), participants received 0.5 mg repaglinide tablet (Day 1, after ≥10 h fast; Reference Treatment 1). On Day 2, they received 1 mg midazolam (0.5 mL oral solution) with 20 mg omeprazole tablet under the same fasting conditions (Reference Treatment 2).\n\nTest (Zongertinib + Repaglinide + Midazolam + Omeprazole)\n\nIn the test treatment period (Period 2), participants received multiple once-daily doses of 120 mg zongertinib from Day 1 to Day 15. A single 0.5 mg repaglinide tablet was co-administered on Day 1 (Test Treatment 1) and Day 14 (Test Treatment 3), and a single dose of the probe drug cocktail containing 1 mg midazolam (0.5 mL oral solution) and 20 mg omeprazole tablet was co-administered on Day 2 (Test Treatment 2) and Day 15 (Test Treatment 4).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.6', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-12', 'size': 938783, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-04T07:25', 'hasProtocol': True}, {'date': '2024-10-25', 'size': 308096, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-04T07:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2024-07-03', 'resultsFirstSubmitDate': '2025-10-15', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)', 'timeFrame': 'Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported.\n\nPeriod 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.'}, {'measure': 'Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.'}, {'measure': 'Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞)', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of omeprazole in plasma over the time interval from 0 extrapolated to infinity ((AUC0-∞) is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.'}, {'measure': 'Maximum Measured Concentration of Repaglinide in Plasma (Cmax)', 'timeFrame': 'Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The maximum measured concentration of repaglinide in plasma is reported.\n\nPeriod 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.'}, {'measure': 'Maximum Measured Concentration of Midazolam in Plasma (Cmax)', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The maximum measured concentration of midazolam in plasma is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.'}, {'measure': 'Maximum Measured Concentration of Omeprazole in Plasma (Cmax)', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The maximum measured concentration of omeprazole in plasma is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data poin is reported.\n\nPeriod 1 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 1): Up to 3 hours pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3-, 4-, 6-, and 24-hours post-dose. Period 2 (Day 14): ≤15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 2.5, 3-, 4-,6-, and 24-hours post-dose.'}, {'measure': 'Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.'}, {'measure': 'Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Samples were collected on Day 2 (Period 1), Day 2 (Period 2), and Day 15 (Period 2). See endpoint description for the full sampling schedule', 'description': 'The area under the concentration-time curve of omeprazole in plasma over the time interval from 0 to the last quantifiable data point is reported.\n\nPeriod 1 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose. Period 2 (Day 2): 15 min pre-dose and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 12 h post-dose. Period 2 (Day 15): 15 min pre-dose, and at 15, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 10, 11, 12 hours post-dose.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests\n* Age of 18 to 55 years (inclusive)\n* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)\n* Signed and dated written informed consent\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06494761', 'briefTitle': 'A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'The Effect of Multiple Doses of Zongertinib on the Single-dose Pharmacokinetics of Midazolam, Omeprazole and Repaglinide in Healthy Male Subjects (an Open-label, 2-period, Fixed-sequence Trial)', 'orgStudyIdInfo': {'id': '1479-0014'}, 'secondaryIdInfos': [{'id': '2023-510263-35-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1301-9035', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)', 'description': 'Reference (Repaglinide + Midazolam + Omeprazole)\n\nIn the reference treatment period (Period 1), participants received 0.5 mg repaglinide tablet (Day 1, after ≥10 h fast; Reference Treatment 1). On Day 2, they received 1 mg midazolam (0.5 mL oral solution) with 20 mg omeprazole tablet under the same fasting conditions (Reference Treatment 2).\n\nTest (Zongertinib + Repaglinide + Midazolam + Omeprazole)\n\nIn the test treatment period (Period 2), participants received multiple once-daily doses of 120 mg zongertinib from Day 1 to Day 15. A single 0.5 mg repaglinide tablet was co-administered on Day 1 (Test Treatment 1) and Day 14 (Test Treatment 3), and a single dose of the probe drug cocktail containing 1 mg midazolam (0.5 mL oral solution) and 20 mg omeprazole tablet was co-administered on Day 2 (Test Treatment 2) and Day 15 (Test Treatment 4).', 'interventionNames': ['Drug: zongertinib', 'Drug: midazolam', 'Drug: omeprazole', 'Drug: repaglinide']}], 'interventions': [{'name': 'zongertinib', 'type': 'DRUG', 'otherNames': ['BI 1810631'], 'description': 'Participants received 120 mg Zongertinib daily as two 60 mg tablets.', 'armGroupLabels': ['Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)']}, {'name': 'midazolam', 'type': 'DRUG', 'description': 'Participants received 1 mg Midazolam as 0.5 mL oral solution.', 'armGroupLabels': ['Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)']}, {'name': 'omeprazole', 'type': 'DRUG', 'description': 'Participants received 20 mg Omeprazole.', 'armGroupLabels': ['Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)']}, {'name': 'repaglinide', 'type': 'DRUG', 'description': 'Participants received a 0.5 mg Repaglinide.', 'armGroupLabels': ['Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88397', 'city': 'Biberach', 'country': 'Germany', 'facility': 'Humanpharmakologisches Zentrum Biberach', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}