Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-02 @ 3:50 AM
Study NCT ID:
NCT03325712
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2017-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").', 'description': 'Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Matching BI 705564', 'description': 'Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Matching BI 705564 - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Limb discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Drug-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching BI 705564', 'description': 'Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).'}, {'id': 'OG001', 'title': 'Placebo Matching BI 705564 - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.'}, {'id': 'OG002', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.'}, {'id': 'OG003', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG004', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG005', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG006', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG007', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '12.5', 'groupId': 'OG006'}, {'value': '75.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564") or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").', 'description': 'Percentage of participants with drug-related adverse events is reported.', 'unitOfMeasure': 'Percentage of participants (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of BI 705564 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.'}, {'id': 'OG001', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG002', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG003', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG004', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG005', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '40.6', 'groupId': 'OG000'}, {'value': '70.8', 'spread': '31.7', 'groupId': 'OG001'}, {'value': '131.0', 'spread': '22.4', 'groupId': 'OG002'}, {'value': '168.0', 'spread': '40.1', 'groupId': 'OG003'}, {'value': '238.0', 'spread': '46.6', 'groupId': 'OG004'}, {'value': '120.0', 'spread': '33.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8188', 'ciLowerLimit': '0.6966', 'ciUpperLimit': '0.9410', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0725', 'estimateComment': 'Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.', 'groupDescription': 'The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).', 'description': 'Area under the concentration-time curve of BI 705564 in plasma over a uniform dosing interval τ after administration of the first dose of BI 705564 (AUCτ,1) is reported. Here AUCτ,1 = AUC0-24.', 'unitOfMeasure': 'nanomole*hour/liter (nmol*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of BI 705564 in Plasma (Cmax) After the Administration of the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.'}, {'id': 'OG001', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG002', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG003', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG004', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG005', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '42.2', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '38.2', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '17.8', 'groupId': 'OG002'}, {'value': '41.0', 'spread': '28.1', 'groupId': 'OG003'}, {'value': '58.1', 'spread': '54.4', 'groupId': 'OG004'}, {'value': '31.7', 'spread': '35.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7708', 'ciLowerLimit': '0.6449', 'ciUpperLimit': '0.8967', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0747', 'estimateComment': 'Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.', 'groupDescription': 'The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).', 'description': 'Maximum measured concentration of BI 705564 in plasma (Cmax) after the administration of the first dose of BI 705564 is reported.', 'unitOfMeasure': 'nanomole/Liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Administration of the Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.'}, {'id': 'OG001', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG002', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG003', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG004', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG005', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '84.8', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '164.0', 'spread': '34.3', 'groupId': 'OG002'}, {'value': '170.0', 'spread': '62.1', 'groupId': 'OG003'}, {'value': '204.0', 'spread': '179.0', 'groupId': 'OG004'}, {'value': '138.0', 'spread': '32.1', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7167', 'ciLowerLimit': '0.4922', 'ciUpperLimit': '0.9412', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1330', 'estimateComment': 'Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.', 'groupDescription': 'The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).', 'description': 'Area under the concentration-time curve of BI 705564 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the administration of the last dose of BI 705564 is reported.\n\nAs per the protocol, day is counted as "Day 1 = 0:00".', 'unitOfMeasure': 'nanomole *hour/liter (nmol*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded. Only participants with evaluable results for this PK parameter are reported.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Administration of the Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.'}, {'id': 'OG001', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG002', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG003', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG004', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG005', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '41.8', 'spread': '21.4', 'groupId': 'OG002'}, {'value': '43.4', 'spread': '57.2', 'groupId': 'OG003'}, {'value': '52.6', 'spread': '201.0', 'groupId': 'OG004'}, {'value': '39.2', 'spread': '28.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6825', 'ciLowerLimit': '0.4556', 'ciUpperLimit': '0.9094', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1344', 'estimateComment': 'Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.', 'groupDescription': 'The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).', 'description': 'Maximum measured concentration of BI 705564 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the administration of the last dose.\n\nAs per the protocol, day is counted as "Day 1 = 0:00".', 'unitOfMeasure': 'nanomole/Liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded. Only participants with evaluable results for this PK parameter are reported.'}, {'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) After the First and Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching BI 705564', 'description': 'Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).'}, {'id': 'OG001', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG002', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG003', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG004', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}], 'classes': [{'title': 'After last dose: Midazolam + BI705564 or Midazolam + Placebo (Treatment (T))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4478.58', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.10', 'groupId': 'OG000'}, {'value': '3463.24', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.06', 'groupId': 'OG001'}, {'value': '4812.45', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.11', 'groupId': 'OG002'}, {'value': '3458.32', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.29', 'groupId': 'OG003'}, {'value': '3759.20', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.10', 'groupId': 'OG004'}]}]}, {'title': 'After first dose: Midazolam alone (Reference (R))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4356.03', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.10', 'groupId': 'OG000'}, {'value': '3721.70', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.06', 'groupId': 'OG001'}, {'value': '4382.24', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.1', 'groupId': 'OG002'}, {'value': '3191.16', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.29', 'groupId': 'OG003'}, {'value': '3445.42', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.10', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.81', 'ciLowerLimit': '87.18', 'ciUpperLimit': '121.25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.5', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG001'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.06', 'ciLowerLimit': '79.94', 'ciUpperLimit': '108.32', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.4', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG002'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.82', 'ciLowerLimit': '103.59', 'ciUpperLimit': '116.42', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.0', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG003'], 'paramType': 'Ratio ( T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.37', 'ciLowerLimit': '92.00', 'ciUpperLimit': '127.66', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.4', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG004'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.11', 'ciLowerLimit': '92.43', 'ciUpperLimit': '128.79', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.6', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.', 'description': 'Area under the concentration-time curve of Midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.', 'unitOfMeasure': 'picomole*hour/Liter (pmol*h/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS)-midazolam set (PKS-Mida): This set included all subjects in dose groups 2 to 5 who received midazolam (including placebo-treated subjects). Only participants with evaluable results for this PK parameter are reported.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of Midazolam in Plasma (Cmax) After the First and Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching BI 705564', 'description': 'Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).'}, {'id': 'OG001', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG002', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG003', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'OG004', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}], 'classes': [{'title': 'After last dose: Midazolam +BI 705564 or Midazolam +Placebo (Treatment (T))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1197.89', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.10', 'groupId': 'OG000'}, {'value': '1040.42', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.09', 'groupId': 'OG001'}, {'value': '1255.36', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.11', 'groupId': 'OG002'}, {'value': '984.14', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.26', 'groupId': 'OG003'}, {'value': '1058.32', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.11', 'groupId': 'OG004'}]}]}, {'title': 'After first dose: Midazolam alone (Reference (R))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1196.63', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.10', 'groupId': 'OG000'}, {'value': '1232.26', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.09', 'groupId': 'OG001'}, {'value': '1147.40', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.11', 'groupId': 'OG002'}, {'value': '1031.18', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.26', 'groupId': 'OG003'}, {'value': '1175.41', 'spread': 'NA', 'comment': 'Standard error is actually adjusted geometric standard error. Geometric standard error=1.11', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.10', 'ciLowerLimit': '83.99', 'ciUpperLimit': '119.31', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.7', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG001'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '84.43', 'ciLowerLimit': '72.29', 'ciUpperLimit': '98.62', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.5', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG002'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.41', 'ciLowerLimit': '94.34', 'ciUpperLimit': '126.88', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.1', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG003'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.44', 'ciLowerLimit': '79.75', 'ciUpperLimit': '114.21', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.1', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}, {'groupIds': ['OG004'], 'paramType': 'Ratio (T/R)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90.04', 'ciLowerLimit': '70.75', 'ciUpperLimit': '114.59', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '25.9', 'estimateComment': 'The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.', 'groupDescription': 'BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for "subjects" and fixed effects for "time point".', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Standard deviation is intra-individual geometric coefficient of variation (%).'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.', 'description': 'Maximum measured concentration of Midazolam in plasma (Cmax) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.', 'unitOfMeasure': 'picomole/Liter (pmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS)-midazolam set (PKS-Mida): This set included all subjects in dose groups 2 to 5 who received midazolam (including placebo-treated subjects). Only participants with evaluable results for this PK parameter are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Matching BI 705564', 'description': 'Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).'}, {'id': 'FG001', 'title': 'Placebo Matching BI 705564 - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.'}, {'id': 'FG002', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.'}, {'id': 'FG003', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'FG004', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'FG005', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'FG006', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'FG007', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The evaluation of multiple rising dose (MRD) of BI 705564 was designed as randomised, placebo-controlled, double-blind and parallel-group design and the evaluation of midazolam interaction was designed as nested, open-label, fixed-sequence, intra-individual comparison in healthy male participants.', 'preAssignmentDetails': 'All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all strictly inclusion/exclusion criteria. Participants were not to be assigned to treatment groups if any of the specific entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Matching BI 705564', 'description': 'Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).'}, {'id': 'BG001', 'title': 'Placebo Matching BI 705564 - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.'}, {'id': 'BG002', 'title': 'Dose Group 1: BI 705564 10 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.'}, {'id': 'BG003', 'title': 'Dose Group 2: BI 705564 20 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'BG004', 'title': 'Dose Group 3: BI 705564 40 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'BG005', 'title': 'Dose Group 5: BI 705564 60 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'BG006', 'title': 'Dose Group 4: BI 705564 80 mg', 'description': 'Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.'}, {'id': 'BG007', 'title': 'Dose Group 8: BI 705564 40 mg - SPT', 'description': 'Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '44.0', 'spread': '5.7', 'groupId': 'BG003'}, {'value': '32.3', 'spread': '9.1', 'groupId': 'BG004'}, {'value': '38.4', 'spread': '8.3', 'groupId': 'BG005'}, {'value': '40.5', 'spread': '10.2', 'groupId': 'BG006'}, {'value': '28.5', 'spread': '10.7', 'groupId': 'BG007'}, {'value': '36.9', 'spread': '9.7', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '55', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-08', 'size': 1220045, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-20T09:49', 'hasProtocol': True}, {'date': '2019-03-14', 'size': 361429, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-15T12:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2017-10-26', 'resultsFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2017-10-26', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-16', 'studyFirstPostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Drug-related Adverse Events', 'timeFrame': 'From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564") or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").', 'description': 'Percentage of participants with drug-related adverse events is reported.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of BI 705564 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1)', 'timeFrame': '1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).', 'description': 'Area under the concentration-time curve of BI 705564 in plasma over a uniform dosing interval τ after administration of the first dose of BI 705564 (AUCτ,1) is reported. Here AUCτ,1 = AUC0-24.'}, {'measure': 'Maximum Measured Concentration of BI 705564 in Plasma (Cmax) After the Administration of the First Dose', 'timeFrame': '1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).', 'description': 'Maximum measured concentration of BI 705564 in plasma (Cmax) after the administration of the first dose of BI 705564 is reported.'}, {'measure': 'Area Under the Concentration-time Curve of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Administration of the Last Dose', 'timeFrame': '1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).', 'description': 'Area under the concentration-time curve of BI 705564 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the administration of the last dose of BI 705564 is reported.\n\nAs per the protocol, day is counted as "Day 1 = 0:00".'}, {'measure': 'Maximum Measured Concentration of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Administration of the Last Dose', 'timeFrame': '1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).', 'description': 'Maximum measured concentration of BI 705564 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the administration of the last dose.\n\nAs per the protocol, day is counted as "Day 1 = 0:00".'}, {'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) After the First and Last Dose', 'timeFrame': '1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.', 'description': 'Area under the concentration-time curve of Midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.'}, {'measure': 'Maximum Measured Concentration of Midazolam in Plasma (Cmax) After the First and Last Dose', 'timeFrame': '1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.', 'description': 'Maximum measured concentration of Midazolam in plasma (Cmax) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to investigate safety and tolerability of BI 705564 in healthy male subjects, following oral administration of multiple rising doses.\n\nSecondary objectives are the exploration of the pharmacokinetics, including dose proportionality and investigation of linearity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Dose Groups (DGs)1 to 5: Healthy male subjects according to the assessment of the investigator, based on a complete medical history, a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests;\n* DG 8, only: Otherwise healthy male subjects (as defined for DGs 1 to 5) with a history (of at least 1 year) of IgE-mediated, perennial allergies, predominantly to (house) dust mite (dermatophagoides pteronyssinus or dermatophagoides farina) as documented by a positive Skin prick test (SPT)(largest diameter of wheal at screening \\> 5 mm)\n\n * Age of 18 to 50 years (incl.)\n * Body Max Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)\n * Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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 judged as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy and/ or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)\n* Diseases of the central nervous system (including but not limited to any kind of seizure or stroke), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts\n* Chronic or relevant acute infections\n* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)\n* Use of drugs within 30 days prior to administration of trial medication, if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)\n* Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug.\n* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)\n* Inability to refrain from smoking on specified trial days\n* Alcohol abuse (consumption of more than 30 g per day)\n* Drug abuse or positive drug screening\n* Blood donation of more than 100 mL within 30 days prior to the administration of trial medication or intended donation during the trial\n* Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial\n* Inability to comply with dietary regimen of the trial site\n* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant Electrocardiogram (ECG) finding at screening\n* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)\n* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study\n\nIn addition, the following trial-specific exclusion criteria apply:\n\n* Male subject with women of child bearing potential (WOCBP) partner who is unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication\n* Subjects who, in the investigator's judgement, are perceived as having an increased risk of bleeding, e.g. history of haemorrhagic disorders, clinical relevant petechial bleeding, occult blood in faeces, haematuria in repeated urine tests, trauma or surgery within the last month planned surgery during trial participation, history of arteriovenous malformation or aneurysm, history of gastroduodenal ulcer disease or gastrointestinal haemorrhage, history of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding, use of drugs that may interfere with haemostasis during trial conduct (e.g. acetylic salicylic acid or other non-steroidal anti-inflammatory drugs)\n* Repeated platelet counts below 100 cells/nL at screening\n* Bleeding times (to monitor platelet function) above reference range at screening\n* Repeated absolute B cell (CD19+) counts below 40/μL at screening\n* Serum potassium below normal range at screening\n* A history or current clinical signs of acute pancreatitis\n* Further exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT03325712', 'briefTitle': 'This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 705564 (Double-blind, Randomised, Placebo-controlled, Parallel-group Design) and Evaluation of Midazolam Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '1408-0002'}, 'secondaryIdInfos': [{'id': '2017-003269-85', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose group 1: BI 705564 10 mg', 'interventionNames': ['Drug: BI 705564']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 2: BI 705564 20 mg', 'interventionNames': ['Drug: BI 705564', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 3: BI 705564 40 mg', 'interventionNames': ['Drug: BI 705564', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 5: BI 705564 60 mg', 'interventionNames': ['Drug: BI 705564', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 4: BI 705564 80 mg', 'interventionNames': ['Drug: BI 705564', 'Drug: Midazolam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matching BI 705564', 'interventionNames': ['Drug: Placebo', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 8: BI 705564 40 mg - SPT', 'description': 'SPT stands for skin prick test.', 'interventionNames': ['Drug: BI 705564']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matching BI 705564 - SPT', 'description': 'SPT stands for skin prick test.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BI 705564', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Dose group 1: BI 705564 10 mg', 'Dose group 2: BI 705564 20 mg', 'Dose group 3: BI 705564 40 mg', 'Dose group 4: BI 705564 80 mg', 'Dose group 5: BI 705564 60 mg', 'Dose group 8: BI 705564 40 mg - SPT']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Placebo matching BI 705564', 'Placebo matching BI 705564 - SPT']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Solution for injection', 'armGroupLabels': ['Dose group 2: BI 705564 20 mg', 'Dose group 3: BI 705564 40 mg', 'Dose group 4: BI 705564 80 mg', 'Dose group 5: BI 705564 60 mg', 'Placebo matching BI 705564']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'CRS Clinical Research Services Mannheim GmbH', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}