Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-31 @ 5:17 AM
Study NCT ID:
NCT03004404
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2016-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'SRD 1-7, 9-10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8: From first drug administration until end of trial (EOT), up to 14 days. BA per treatment: From first drug administration until end of trial (EOT), up to 14 days.', 'description': 'Treated set (TS): This subject set included all subjects from the Randomised set (RS) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.\n\nParticipants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. 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': 'EG004', 'title': 'SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One 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': 'EG005', 'title': 'SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. 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': 'EG006', 'title': 'SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One 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': 'EG007', 'title': 'SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2', 'description': 'Participants were administered on Day 1 of period 2 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. 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': 'EG011', 'title': 'BA Part: BI 730357 Tablet 25 mg Fasted (R)', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'BA Part: BI 730357 PfOS 25 mg Fasted (T1)', 'description': 'Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'BA Part: BI 730357 Tablet 25 mg Fed (T2)', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Medical device site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'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': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, '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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'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': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Drug-related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '12', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.\n\nParticipants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG002', 'title': 'SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG003', 'title': 'SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG004', 'title': 'SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG005', 'title': 'SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG006', 'title': 'SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG007', 'title': 'SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG008', 'title': 'SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG009', 'title': 'SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2', 'description': 'Participants were administered on Day 1 of period 2 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG010', 'title': 'SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG011', 'title': 'BA Part: BI 730357 Tablet 25 mg Fasted (R)', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG012', 'title': 'BA Part: BI 730357 PfOS 25 mg Fasted (T1)', 'description': 'Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG013', 'title': 'BA Part: BI 730357 Tablet 25 mg Fed (T2)', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '16.7', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}, {'value': '0.0', 'groupId': 'OG012'}, {'value': '0.0', 'groupId': 'OG013'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.', 'description': 'Percentage of subjects with adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported.\n\nFed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): This subject set included all subjects from the Randomised set (RS) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG002', 'title': 'SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG003', 'title': 'SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG004', 'title': 'SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG005', 'title': 'SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG006', 'title': 'SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG007', 'title': 'SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG008', 'title': 'SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG009', 'title': 'SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG010', 'title': 'BA Part: BI 730357 Tablet 25 mg Fasted (R)', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG011', 'title': 'BA Part: BI 730357 PfOS 25 mg Fasted (T1)', 'description': 'Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG012', 'title': 'BA Part: BI 730357 Tablet 25 mg Fed (T2)', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '399.0', 'spread': '35.0', 'groupId': 'OG000'}, {'value': '1550.0', 'spread': '27.8', 'groupId': 'OG001'}, {'value': '3730.0', 'spread': '36.4', 'groupId': 'OG002'}, {'value': '6990.0', 'spread': '52.7', 'groupId': 'OG003'}, {'value': '10700.0', 'spread': '60.2', 'groupId': 'OG004'}, {'value': '18300.0', 'spread': '28.0', 'groupId': 'OG005'}, {'value': '30800.0', 'spread': '36.8', 'groupId': 'OG006'}, {'value': '44800.0', 'spread': '41.5', 'groupId': 'OG007'}, {'value': '50700.0', 'spread': '57.5', 'groupId': 'OG008'}, {'value': '77900.0', 'spread': '38.3', 'groupId': 'OG009'}, {'value': '4240.0', 'spread': '45.0', 'groupId': 'OG010'}, {'value': '5390.0', 'spread': '43.8', 'groupId': 'OG011'}, {'value': '5370.0', 'spread': '44.6', 'groupId': 'OG012'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7480', 'ciLowerLimit': '0.5959', 'ciUpperLimit': '0.9001', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0743', 'estimateComment': 'Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.', 'groupDescription': 'In the SRD part of the trial, dose proportionality for AUC0-inf was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG007', 'OG008'], 'paramType': 'Ratio T/R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118.71', 'ciLowerLimit': '94.57', 'ciUpperLimit': '149.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.11', 'estimateComment': 'Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.', 'groupDescription': 'Relative bioavailability of AUC0-inf for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an Analysis of Variance (ANOVA) model on the logarithmic scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG010', 'OG011'], 'paramType': 'Geometric mean ratio T1/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '124.79', 'ciLowerLimit': '116.858', 'ciUpperLimit': '133.255', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.036', 'estimateComment': 'Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.', 'groupDescription': "Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Auc0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.'}, {'groupIds': ['OG010', 'OG012'], 'paramType': 'Geometric mean ratio T2/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '125.17', 'ciLowerLimit': '112.89', 'ciUpperLimit': '138.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'estimateComment': 'Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.', 'groupDescription': "Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Relative bioavailability of BI 730357 for tablet fed (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of AUC0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration', 'description': 'Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity is reported.\n\nFed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.', 'unitOfMeasure': 'nanomol*hour/liter (nmol*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): The PKS included all subjects who were treated with BI 730357 and who provided at least 1 secondary PK endpoint (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of BI 730357 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG001', 'title': 'SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG002', 'title': 'SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG003', 'title': 'SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG004', 'title': 'SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG005', 'title': 'SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG006', 'title': 'SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG007', 'title': 'SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG008', 'title': 'SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG009', 'title': 'SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG010', 'title': 'BA Part: BI 730357 Tablet 25 mg Fasted (R)', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG011', 'title': 'BA Part: BI 730357 PfOS 25 mg Fasted (T1)', 'description': 'Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) together with about 240 mL of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'OG012', 'title': 'BA Part: BI 730357 Tablet 25 mg Fed (T2)', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2) together with about 240 mL of water, a high-fat, high-calorie breakfast was served 30 min before dose administration. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '154.0', 'spread': '28.9', 'groupId': 'OG001'}, {'value': '103.0', 'spread': '31.7', 'groupId': 'OG002'}, {'value': '173.0', 'spread': '41.9', 'groupId': 'OG003'}, {'value': '284.0', 'spread': '30.7', 'groupId': 'OG004'}, {'value': '433.0', 'spread': '27.6', 'groupId': 'OG005'}, {'value': '755.0', 'spread': '37.4', 'groupId': 'OG006'}, {'value': '1270.0', 'spread': '17.5', 'groupId': 'OG007'}, {'value': '1900.0', 'spread': '30.2', 'groupId': 'OG008'}, {'value': '2470.0', 'spread': '15.7', 'groupId': 'OG009'}, {'value': '133.0', 'spread': '31.4', 'groupId': 'OG010'}, {'value': '380.0', 'spread': '27.4', 'groupId': 'OG011'}, {'value': '235.0', 'spread': '28.5', 'groupId': 'OG012'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7065', 'ciLowerLimit': '0.5863', 'ciUpperLimit': '0.8267', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0587', 'estimateComment': 'Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1', 'groupDescription': 'In the SRD part of the trial, dose proportionality for Cmax was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG007', 'OG008'], 'paramType': 'Ratio T/R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '151.22', 'ciLowerLimit': '122.781', 'ciUpperLimit': '186.248', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.107', 'estimateComment': 'Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.', 'groupDescription': 'Relative bioavailability of the Cmax for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an ANOVA model on the logarithmic scale.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG010', 'OG011'], 'paramType': 'Geometric mean ratio T1/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '293.21', 'ciLowerLimit': '259.044', 'ciUpperLimit': '331.891', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.069', 'estimateComment': 'Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.', 'groupDescription': "Estimation of relative bioavailability of Cmax based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.'}, {'groupIds': ['OG010', 'OG012'], 'paramType': 'Geometric mean ratio T2/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '180.53', 'ciLowerLimit': '162.369', 'ciUpperLimit': '200.732', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.059', 'estimateComment': 'Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.', 'groupDescription': "Estimation of relative bioavailability of Cmax was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Relative bioavailability of BI 730357 for tablet fasted (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration', 'description': 'Maximum measured concentration of BI 730357 in plasma is reported.\n\nFed1 means intake of continental breakfast; Fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.', 'unitOfMeasure': 'nanomol / liter (nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): The PKS included all subjects who were treated with BI 730357 and who provided at least 1 secondary PK endpoint (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.\n\nParticipants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG001', 'title': 'SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG002', 'title': 'SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG003', 'title': 'SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG004', 'title': 'SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG005', 'title': 'SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG006', 'title': 'SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG007', 'title': 'SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG008', 'title': 'SRD Part-Dose Group 8-9: BI 730357 Tablet(s) 400 mg Fed', 'description': 'The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast.\n\nDG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast.\n\nBoth treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG009', 'title': 'SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG010', 'title': 'BA Part: R/T2/T1', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nFollowed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG011', 'title': 'BA Part: R/T1/T2', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nFollowed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG012', 'title': 'BA Part: T2/R/T1', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG013', 'title': 'BA Part: T2/T1/R', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG014', 'title': 'BA Part: T1/R/T2', 'description': 'Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nParticipants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'FG015', 'title': 'BA Part: T1/T2/R', 'description': 'Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nParticipants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '2'}]}, {'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'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', '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': '6'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '2'}]}, {'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': '5'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '1'}]}, {'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': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'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': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}]}]}, {'title': 'Period 3', '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': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '1'}]}, {'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': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '1'}]}, {'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'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study had two parts, single rising dose (SRD): partially randomized, single-blind, placebo-controlled, parallel group design to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 730357. Bioavailability/food effect (BA/FE) part: Single dose, randomised, open-label, intra-individual three-way crossover to investigate the relative BA of the tablet formulation versus oral solution as well as the influence of food on the bioavailability of the tablet formulation.', 'preAssignmentDetails': 'All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '84', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.\n\nParticipants were administered on Day 1 a single oral dose of matching placebo, for dose group (DG) 1-2 the matching placebo was solvent for oral solution containing Macrogol 400 (Polyethylene glycol 400) on a volume identical to dose group of active treatment, for DG 3-7 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fasted state. For DG 8-10 the matching placebo were single oral film-coated tablet(s) with about 240 milliliter (mL) of water on fed state, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast/continental breakfast depending on dose group. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG001', 'title': 'SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG002', 'title': 'SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG003', 'title': 'SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG004', 'title': 'SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG005', 'title': 'SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG006', 'title': 'SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG007', 'title': 'SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG008', 'title': 'SRD Part-Dose Group 8-9: BI 730357 Tablet(s) 400 mg Fed', 'description': 'The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast.\n\nDG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast.\n\nBoth treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG009', 'title': 'SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG010', 'title': 'BA Part', 'description': 'In the BA part of the trial, subjects were randomised to 6 treatment sequences. All subjects were administered BI 730357 as tablet in fasted condition (R), as oral solution in fasted condition (T1), and as tablet after a standardised high-fat breakfast (T2). The 3 treatments were separated by a wash-out period of at least 8 days between trial drug administrations. One authorized employee of the trial site was witness of the administration of the trial medication.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '30.7', 'spread': '6.7', 'groupId': 'BG003'}, {'value': '30.2', 'spread': '8.7', 'groupId': 'BG004'}, {'value': '31.3', 'spread': '5.0', 'groupId': 'BG005'}, {'value': '30.2', 'spread': '7.9', 'groupId': 'BG006'}, {'value': '34.5', 'spread': '5.9', 'groupId': 'BG007'}, {'value': '30.8', 'spread': '7.0', 'groupId': 'BG008'}, {'value': '31.7', 'spread': '5.5', 'groupId': 'BG009'}, {'value': '35.3', 'spread': '8.6', 'groupId': 'BG010'}, {'value': '32.6', 'spread': '6.7', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Treated set'}, {'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': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '84', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Treated Set'}, {'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': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '84', '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', 'description': 'TS', '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': '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': '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': '1', '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': '1', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '83', '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'}], 'populationDescription': 'Treated Set (TS): The Treated set (TS) included all subjects from the Randomised set (RS) who were documented to have taken at least 1 dose of trial medication. The TS for the SRD part included 72 subjects. The TS for the BA part included all 12 treated subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-05', 'size': 5441079, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-11T05:55', 'hasProtocol': True}, {'date': '2017-09-22', 'size': 327732, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-11T05:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2016-12-23', 'resultsFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Drug-related Adverse Events (AEs)', 'timeFrame': 'SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.', 'description': 'Percentage of subjects with adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported.\n\nFed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)', 'timeFrame': 'SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration', 'description': 'Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity is reported.\n\nFed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.'}, {'measure': 'Maximum Measured Concentration of BI 730357 in Plasma (Cmax)', 'timeFrame': 'SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration', 'description': 'Maximum measured concentration of BI 730357 in plasma is reported.\n\nFed1 means intake of continental breakfast; Fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730357 in healthy subjects following oral administration of single rising doses after fasting and/or non-fasting conditions. The secondary objective is the exploration of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI 730357 after single dosing.\n\nThe objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative bioavailability of tablet fasted versus oral solution fasted and the influence of food on the bioavailability of tablet fasted versus tablet fed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male according to the Investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests\n* Age of 18 to 45 years (incl.)\n* Body Mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)\n* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the Investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)\n* Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance\n* Any evidence of a concomitant disease judged as clinically relevant by the Investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts\n* Chronic or relevant acute infections\n* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)\n* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc (corrected QT) interval prolongation)\n* Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug\n* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)\n* Inability to refrain from smoking on specified trial days\n* Alcohol abuse (consumption of more 30 g per day for males)\n* Drug abuse or positive drug screening\n* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial\n* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial\n* Inability to comply with dietary regimen of trial site\n* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening\n* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)\n* Subject is assessed as unsuitable for inclusion by the Investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study\n\nIn addition, the following trial-specific exclusion criteria apply:\n\n\\- Male subjects with Women of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}, 'identificationModule': {'nctId': 'NCT03004404', 'briefTitle': 'To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 730357 Administered as Oral Solution and Tablets to Healthy Subjects, and a Randomized, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 730357 as Tablet Versus Oral Solution and Tablet With and Without Food', 'orgStudyIdInfo': {'id': '1407.1'}, 'secondaryIdInfos': [{'id': '2016-003047-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state.\n\nOne authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed', 'description': 'The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast.\n\nDG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast.\n\nBoth treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed', 'description': 'Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'BA Part: R/T2/T1', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nFollowed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'BA Part: R/T1/T2', 'description': 'Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nFollowed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'BA Part: T2/R/T1', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'BA Part: T2/T1/R', 'description': 'Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nParticipants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'BA Part: T1/R/T2', 'description': 'Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nParticipants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}, {'type': 'EXPERIMENTAL', 'label': 'BA Part: T1/T2/R', 'description': 'BA Part: T1/T2/R Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state.\n\nParticipants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration.\n\nFollowed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state.\n\nThe 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.', 'interventionNames': ['Drug: BI 730357']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'BI 730357', 'type': 'DRUG', 'description': 'powder for reconstitution of an oral solution (PfoS)', 'armGroupLabels': ['BA Part: R/T1/T2', 'BA Part: R/T2/T1', 'BA Part: T1/R/T2', 'BA Part: T1/T2/R', 'BA Part: T2/R/T1', 'BA Part: T2/T1/R', 'SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted', 'SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted']}, {'name': 'BI 730357', 'type': 'DRUG', 'description': 'BI 730357 film-coated tablet', 'armGroupLabels': ['BA Part: R/T1/T2', 'BA Part: R/T2/T1', 'BA Part: T1/R/T2', 'BA Part: T1/T2/R', 'BA Part: T2/R/T1', 'BA Part: T2/T1/R', 'SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed', 'SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted', 'SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted', 'SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted', 'SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted', 'SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted', 'SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88397', 'city': 'Biberach', 'country': 'Germany', 'facility': 'Humanpharmakologisches Zentrum Biberach', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}