Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-07 @ 4:19 AM
Study NCT ID:
NCT04619251
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, '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': 'Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole.', 'description': 'Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug.\n\nThe Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.', 'eventGroups': [{'id': 'EG000', 'title': 'SRD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo).\n\nParticipants were administered on Day 1 a single oral dose of placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part MD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SRD Part: PM Subjects, BI1323495 10mg', 'description': 'Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SRD Part: PM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SRD Part: PM Subjects, BI1323495 100mg', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'SRD Part: EM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'SRD Part: EM Subjects, BI1323495 70mg', 'description': 'Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'SRD Part: EM Subjects, BI1323495 150mg', 'description': 'Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'DDI Part: PM Subjects, BI1323495', 'description': 'During period 1, participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'DDI Part: PM Subjects, Itraconazole', 'description': 'During period 2, participants were administered the test treatment (T) which consisted of multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation, together with of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'DDI Part: PM Subjects, BI1323495+ Itraconazole', 'description': 'During period 2, participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophageal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SRD and MD Part: Number of Participants With Drug-related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'SRD Part: PM Subjects, BI1323495 10mg', 'description': 'Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'SRD Part: PM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG002', 'title': 'SRD Part: PM Subjects, BI1323495 100mg', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG003', 'title': 'SRD Part: EM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG004', 'title': 'SRD Part: EM Subjects, BI1323495 70mg', 'description': 'Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG005', 'title': 'SRD Part: EM Subjects, BI1323495 150mg', 'description': 'Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG006', 'title': 'SRD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo).\n\nParticipants were administered on Day 1 a single oral dose of placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG007', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG008', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication'}, {'id': 'OG009', 'title': 'MD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part MD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days (for SRD part), up to 17 days (for MD part).', 'description': 'Number of participants with drug-related adverse events (AEs) is reported for Single rising dose (SRD) and Multiple dose (MD) parts is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): The treated set includes all subjects who were randomised (SRD and MD part) and treated with at least one dose of trial drug. As pre-specified in the protocol this endpoint only includes the SRD and MD part of the study.'}, {'type': 'PRIMARY', 'title': 'DDI Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDI Part: BI1323495, Period 1', 'description': 'Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.'}, {'id': 'OG001', 'title': 'DDI Part: BI1323495+Itraconazole, Period 2', 'description': 'Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '757.8', 'spread': 'NA', 'comment': 'The standard error is actually the geometric standard error and is equal to 1.054.', 'groupId': 'OG000'}, {'value': '2558.3', 'spread': 'NA', 'comment': 'The standard error is actually the geometric standard error and is equal to 1.052', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '337.6', 'ciLowerLimit': '302.8', 'ciUpperLimit': '376.4', 'estimateComment': 'Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =15.9', 'groupDescription': "The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).', 'description': "The area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.", 'unitOfMeasure': 'hour * nanomol / liter (h*nmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included.'}, {'type': 'PRIMARY', 'title': 'DDI Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDI Part: BI1323495, Period 1', 'description': 'Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.'}, {'id': 'OG001', 'title': 'DDI Part: BI1323495+ Itraconazole, Period 2', 'description': 'Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication, Administration of BI 1323495 in treatment R and T were separated by at least 11 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.2', 'spread': 'NA', 'comment': 'The standard error is actually the geometric standard error and is equal to 1.072.', 'groupId': 'OG000'}, {'value': '149.7', 'spread': 'NA', 'comment': 'The standard error is actually the geometric standard error and is equal to 1.072.', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '184.4', 'ciLowerLimit': '156.0', 'ciUpperLimit': '218.0', 'estimateComment': 'Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =26.4', 'groupDescription': "The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).', 'description': "Maximum measured concentration of BI 1323495 in plasma is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.", 'unitOfMeasure': 'nanomol / liter (nmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.'}, {'type': 'SECONDARY', 'title': 'DDI Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDI Part: BI1323495, Period 1', 'description': 'Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.'}, {'id': 'OG001', 'title': 'DDI Part: BI1323495+ Itraconazole, Period 2', 'description': 'Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '704.5', 'spread': 'NA', 'comment': 'The standard error is actually the geometric standard error and is equal to 1.056.', 'groupId': 'OG000'}, {'value': '2513.8', 'spread': 'NA', 'comment': 'The standard error is actually the geometric standard error and is equal to 1.056.', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '356.8', 'ciLowerLimit': '315.7', 'ciUpperLimit': '403.2', 'estimateComment': 'Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =18.4', 'groupDescription': "The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).', 'description': "The area under the concentration-time curve BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.", 'unitOfMeasure': 'hour * nanomol / liter (h*nmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.'}, {'type': 'SECONDARY', 'title': 'SRD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'SRD Part: PM Subjects, BI1323495 10mg', 'description': 'Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'SRD Part: PM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG002', 'title': 'SRD Part: PM Subjects, BI1323495 100mg', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG003', 'title': 'SRD Part: EM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG004', 'title': 'SRD Part: EM Subjects, BI1323495 70mg', 'description': 'Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG005', 'title': 'SRD Part: EM Subjects, BI1323495 150mg', 'description': 'Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '776', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '2140', 'spread': '25.7', 'groupId': 'OG001'}, {'value': '6700', 'spread': '13.9', 'groupId': 'OG002'}, {'value': '715', 'spread': '55.0', 'groupId': 'OG003'}, {'value': '4040', 'spread': '25.6', 'groupId': 'OG004'}, {'value': '3550', 'spread': '42.2', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 48h, 72h, 96h after start of BI 1323495 administration. Additionally only in the PM group: at 120h, 144h, and 168h.', 'description': 'The area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.', 'unitOfMeasure': 'hour * nanomol / liter (h*nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included.'}, {'type': 'SECONDARY', 'title': 'SRD Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'SRD Part: PM Subjects, BI1323495 10mg', 'description': 'Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'SRD Part: PM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG002', 'title': 'SRD Part: PM Subjects, BI1323495 100mg', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG003', 'title': 'SRD Part: EM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG004', 'title': 'SRD Part: EM Subjects, BI1323495 70mg', 'description': 'Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG005', 'title': 'SRD Part: EM Subjects, BI1323495 150mg', 'description': 'Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '276', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '643', 'spread': '9.15', 'groupId': 'OG002'}, {'value': '86.9', 'spread': '37.0', 'groupId': 'OG003'}, {'value': '196', 'spread': '8.72', 'groupId': 'OG004'}, {'value': '230', 'spread': '54.9', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 48h, 72h, 96h after start of BI 1323495 administration. Additionally only in the PM group: at 120h, 144h, and 168h.', 'description': 'Maximum measured concentration of BI 1323495 in plasma (Cmax) is reported.', 'unitOfMeasure': 'nanomol / liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.'}, {'type': 'SECONDARY', 'title': 'MD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval of 12 h After Administration of the First Dose (AUC0-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '1520', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '2350', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, after start of first dose BI 1323495 administration.', 'description': 'The area under the concentration-time curve of BI 1323495 in plasma over the time interval of 12 h after administration of the first dose (AUC0-12) is reported.', 'unitOfMeasure': 'hour * nanomol / liter (h*nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.'}, {'type': 'SECONDARY', 'title': 'MD Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax) After First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '303', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '431', 'spread': '15.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, after start of first dose BI 1323495 administration.', 'description': 'Maximum measured concentration of BI 1323495 in plasma (Cmax) after first dose is reported.', 'unitOfMeasure': 'nanomol / liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.'}, {'type': 'SECONDARY', 'title': 'MD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After Last Dose Administration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '2600', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '4770', 'spread': '17.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 15 minutes (min) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h (only for the 60mg qd administration) after last dose administration.', 'description': 'Area under the concentration-time curve of BI 1323495 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after last dose administration is reported. T for 30 mg bid is 12h, for 60 mg qd is 24h.', 'unitOfMeasure': 'hour * nanomol / liter (h*nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.'}, {'type': 'SECONDARY', 'title': 'MD Part: Maximum Measured Concentration of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication'}], 'classes': [{'categories': [{'measurements': [{'value': '417', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '570', 'spread': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Within 15 minutes (min) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h (only for the 60mg qd administration) after last dose administration.', 'description': 'Maximum measured concentration of BI 1323495 in plasma (Cmax,ss) at steady state over a uniform dosing interval τ is reported. T for 30 mg bid is 12h, for 60 mg qd is 24h.', 'unitOfMeasure': 'nanomol / liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SRD Part: PM Subjects, BI1323495 10mg', 'description': 'Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG001', 'title': 'SRD Part: PM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG002', 'title': 'SRD Part: PM Subjects, BI1323495 100mg', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG003', 'title': 'SRD Part: EM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG004', 'title': 'SRD Part: EM Subjects, BI1323495 70mg', 'description': 'Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG005', 'title': 'SRD Part: EM Subjects, BI1323495 150mg', 'description': 'Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG006', 'title': 'SRD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo).\n\nParticipants were administered on Day 1 a single oral dose of placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG007', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG008', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG009', 'title': 'MD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part MD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG010', 'title': 'DDI Part: PM Subjects, BI1323495 / BI1323495+ Itraconazole', 'description': '* Period 1: Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication.\n* Period 2: Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a two part clinical trial, the first part was single rising dose (SRD) and multiple dose (MD), the second part evaluates drug-drug interaction (DDI) with itraconazole. The study was performed in healthy Japanese men genotyped as poor metabolizers (PM) or as extensive metabolizers (EM) to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the blood.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Administrations of BI 1323495 was separated by a wash-out phase of at least 11 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '74', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'SRD Part: PM Subjects, BI1323495 10mg', 'description': 'Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG001', 'title': 'SRD Part: PM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG002', 'title': 'SRD Part: PM Subjects, BI1323495 100mg', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG003', 'title': 'SRD Part: EM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG004', 'title': 'SRD Part: EM Subjects, BI1323495 70mg', 'description': 'Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG005', 'title': 'SRD Part: EM Subjects, BI1323495 150mg', 'description': 'Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG006', 'title': 'SRD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo).\n\nParticipants were administered on Day 1 a single oral dose of placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG007', 'title': 'MD Part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG008', 'title': 'MD Part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG009', 'title': 'MD Part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part MD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG010', 'title': 'DDI Part: PM Subjects, BI1323495 / BI1323495+ Itraconazole', 'description': '* Period 1: Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication.\n* Period 2: Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '33.5', 'spread': '7.6', 'groupId': 'BG002'}, {'value': '24.7', 'spread': '3.1', 'groupId': 'BG003'}, {'value': '33.0', 'spread': '4.6', 'groupId': 'BG004'}, {'value': '29.3', 'spread': '5.5', 'groupId': 'BG005'}, {'value': '29.3', 'spread': '7.0', 'groupId': 'BG006'}, {'value': '32.3', 'spread': '5.6', 'groupId': 'BG007'}, {'value': '28.6', 'spread': '4.6', 'groupId': 'BG008'}, {'value': '30.0', 'spread': '6.5', 'groupId': 'BG009'}, {'value': '30.4', 'spread': '7.2', 'groupId': 'BG010'}, {'value': '30.0', 'spread': '6.6', 'groupId': 'BG011'}]}]}], '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '74', 'groupId': 'BG011'}]}]}], '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '74', 'groupId': 'BG011'}]}, {'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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '74', 'groupId': 'BG011'}]}, {'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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'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': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'White', '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'More than one race', '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): The treated set includes all subjects who were randomised (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The treatment assignment will be determined based on the first treatment the subjects received. The treated set will be used for safety analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-25', 'size': 1080369, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-04T07:47', 'hasProtocol': True}, {'date': '2021-08-27', 'size': 249655, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-04T07:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2020-10-28', 'resultsFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-07', 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SRD and MD Part: Number of Participants With Drug-related Adverse Events (AEs)', 'timeFrame': 'Up to 7 days (for SRD part), up to 17 days (for MD part).', 'description': 'Number of participants with drug-related adverse events (AEs) is reported for Single rising dose (SRD) and Multiple dose (MD) parts is reported.'}, {'measure': 'DDI Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).', 'description': "The area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale."}, {'measure': 'DDI Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).', 'description': "Maximum measured concentration of BI 1323495 in plasma is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale."}], 'secondaryOutcomes': [{'measure': 'DDI Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).', 'description': "The area under the concentration-time curve BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale."}, {'measure': 'SRD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 48h, 72h, 96h after start of BI 1323495 administration. Additionally only in the PM group: at 120h, 144h, and 168h.', 'description': 'The area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.'}, {'measure': 'SRD Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 48h, 72h, 96h after start of BI 1323495 administration. Additionally only in the PM group: at 120h, 144h, and 168h.', 'description': 'Maximum measured concentration of BI 1323495 in plasma (Cmax) is reported.'}, {'measure': 'MD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval of 12 h After Administration of the First Dose (AUC0-12)', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, after start of first dose BI 1323495 administration.', 'description': 'The area under the concentration-time curve of BI 1323495 in plasma over the time interval of 12 h after administration of the first dose (AUC0-12) is reported.'}, {'measure': 'MD Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax) After First Dose', 'timeFrame': 'Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, after start of first dose BI 1323495 administration.', 'description': 'Maximum measured concentration of BI 1323495 in plasma (Cmax) after first dose is reported.'}, {'measure': 'MD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After Last Dose Administration.', 'timeFrame': 'Within 15 minutes (min) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h (only for the 60mg qd administration) after last dose administration.', 'description': 'Area under the concentration-time curve of BI 1323495 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after last dose administration is reported. T for 30 mg bid is 12h, for 60 mg qd is 24h.'}, {'measure': 'MD Part: Maximum Measured Concentration of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)', 'timeFrame': 'Within 15 minutes (min) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h (only for the 60mg qd administration) after last dose administration.', 'description': 'Maximum measured concentration of BI 1323495 in plasma (Cmax,ss) at steady state over a uniform dosing interval τ is reported. T for 30 mg bid is 12h, for 60 mg qd is 24h.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the single-rising dose (SRD) part and the multiple rising dose (MD) part is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics (for MD part only) following single rising doses and multiple oral doses of BI 1323495 in healthy male Japanese subjects genotyped as poor metabolizers (PM) and extensive metabolizers (EM) of UGT2B17.\n\nThe main objective of the drug-drug interaction (DDI) part is to investigate the relative bioavailability of a single oral dose of BI 1323495 when given alone (treatment R) or in combination with itraconazole (treatment T) in healthy male subjects genotyped as PM of UGT2B17.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a medical examination, vital signs (BP, PR), 12- lead ECG, and clinical laboratory tests\n* Japanese ethnicity, according to the following criteria:\n\n --born in Japan, have lived outside of Japan \\<10 years, and have parents and grandparents who are Japanese\n* Age of 20 to 45 years (inclusive) at screening\n* BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening\n* Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation\n* Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication\n* Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.\n* Vasectomized (vasectomy at least 1 year prior to enrolment)\n* Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner\n* Subjects genotyped as UGT2B17 poor metabolizers, i.e. carrying allele of UGT2B17 gene (\\*2/\\*2) (DDI part only)\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 bpm\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n* Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04619251', 'briefTitle': 'A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1323495 Versus Placebo in Healthy Male Japanese Subjects Genotyped as Poor and Extensive Metabolizers of UGT2B17 (Single-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial), Including an Investigation of Drug-drug Interaction With Itraconazole in Healthy Male Subjects Genotyped as Poor Metabolizers of UGT2B17 (an Open-label, Two-period, Fixed Sequence Trial)', 'orgStudyIdInfo': {'id': '1405-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SRD part: PM Subjects, BI1323495 10mg', 'description': 'Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part: PM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part: PM Subjects, BI1323495 100mg', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part: EM Subjects, BI1323495 30mg', 'description': 'Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part: EM Subjects, BI1323495 70mg', 'description': 'Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part: EM Subjects, BI1323495 150mg', 'description': 'Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SRD part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo).\n\nParticipants were administered on Day 1 a single oral dose of placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MD part: PM Subjects, BI1323495 30mg BID', 'description': 'Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'EXPERIMENTAL', 'label': 'MD part: PM Subjects, BI1323495 60mg QD', 'description': 'Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 1323495']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MD part: Placebo', 'description': 'This arm comprises all placebo treated participants in trial part MD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DDI part: PM Subjects, BI1323495 / BI1323495+ Itraconazole', 'description': '* Period 1: Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication.\n* Period 2: Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication.\n\nAdministration of BI 1323495 in treatment R and T were separated by at least 11 days.', 'interventionNames': ['Drug: BI 1323495', 'Drug: Itraconazole']}], 'interventions': [{'name': 'BI 1323495', 'type': 'DRUG', 'description': 'BI 1323495', 'armGroupLabels': ['DDI part: PM Subjects, BI1323495 / BI1323495+ Itraconazole', 'MD part: PM Subjects, BI1323495 30mg BID', 'MD part: PM Subjects, BI1323495 60mg QD', 'SRD part: EM Subjects, BI1323495 150mg', 'SRD part: EM Subjects, BI1323495 30mg', 'SRD part: EM Subjects, BI1323495 70mg', 'SRD part: PM Subjects, BI1323495 100mg', 'SRD part: PM Subjects, BI1323495 10mg', 'SRD part: PM Subjects, BI1323495 30mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['MD part: Placebo', 'SRD part: Placebo']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Itraconazole', 'armGroupLabels': ['DDI part: PM Subjects, BI1323495 / BI1323495+ Itraconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-0004', 'city': 'Tokyo, Sumida-ku', 'country': 'Japan', 'facility': 'SOUSEIKAI Sumida Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datasharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}