[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396667":3},{"organization":4,"armGroups":7,"interventions":68,"overallOfficials":73,"centralContacts":73,"locations":77,"responsibleParty":90,"collaborators":73,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":73,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":73,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":73,"overallStatus":111,"whyStopped":73,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14,20,24,28,32,36,40,44,48,52,56,60,64],{"label":9,"type":10,"description":11,"interventionNames":12},"SRD part: Placebo","PLACEBO_COMPARATOR","This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo).\n\nParticipants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg\u002FmL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"SRD part: 0.25mg BI 1569912","EXPERIMENTAL","Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[19],"Drug: BI 1569912",{"label":21,"type":16,"description":22,"interventionNames":23},"SRD part: 0.75mg BI 1569912","Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[19],{"label":25,"type":16,"description":26,"interventionNames":27},"SRD part: 2.0 mg BI 1569912","Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[19],{"label":29,"type":16,"description":30,"interventionNames":31},"SRD part: 5.0 mg BI 1569912","Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[19],{"label":33,"type":16,"description":34,"interventionNames":35},"SRD part: 10.0 mg BI 1569912","Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[19],{"label":37,"type":16,"description":38,"interventionNames":39},"SRD part: 20.0 mg BI 1569912","Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[19],{"label":41,"type":16,"description":42,"interventionNames":43},"SRD part: 30.0 mg BI 1569912","Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.",[19],{"label":45,"type":16,"description":46,"interventionNames":47},"BA\u002FFE Part: BI 1569912 5.0 mg oral solution fasted\u002F5.0 mg tablet fasted\u002F5.0 mg tablet fed","Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration.\n\nOne authorized employee of the trial site witnessed the administration of trial medication.\n\nThe treatments were separated by a washout phase of at least 5 days between treatments.",[19],{"label":49,"type":16,"description":50,"interventionNames":51},"BA\u002FFE Part: BI 1569912 5.0 mg oral solution fasted\u002F5.0 mg tablet fed\u002F5.0 mg tablet fasted","Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nOne authorised employee of the trial site witnessed the administration of trial medication.\n\nThe treatments were separated by a washout phase of at least 5 days between treatments.",[19],{"label":53,"type":16,"description":54,"interventionNames":55},"BA\u002FFE Part: BI 1569912 5.0 mg tablet fasted\u002F5.0 mg oral solution fasted\u002F5.0 mg tablet fed","Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration.\n\nOne authorised employee of the trial site witnessed the administration of trial medication.\n\nThe treatments were separated by a washout phase of at least 5 days between treatments.",[19],{"label":57,"type":16,"description":58,"interventionNames":59},"BA\u002FFE Part: BI 1569912 5.0 mg tablet fasted\u002F5.0 mg tablet fed\u002F5.0 mg oral solution fasted","Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nOne authorised employee of the trial site witnessed the administration of trial medication.\n\nThe treatments were separated by a washout phase of at least 5 days between treatments.",[19],{"label":61,"type":16,"description":62,"interventionNames":63},"BA\u002FFE Part: BI 1569912 5.0 mg tablet fed\u002F5.0 mg oral solution fasted\u002F5.0 mg tablet fasted","Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nOne authorised employee of the trial site witnessed the administration of trial medication.\n\nThe treatments were separated by a washout phase of at least 5 days between treatments.",[19],{"label":65,"type":16,"description":66,"interventionNames":67},"BA\u002FFE Part: BI 1569912 5.0 mg tablet fed\u002F5.0 mg tablet fasted\u002F5.0 mg oral solution fasted","Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nFollowed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg\u002FmL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.\n\nOne authorised employee of the trial site witnessed the administration of trial medication.\n\nThe treatments were separated by a washout phase of at least 5 days between treatments.",[19],[69,74],{"type":70,"name":71,"description":71,"armGroupLabels":72,"otherNames":73},"DRUG","BI 1569912",[45,49,53,57,61,65,15,21,33,25,37,41,29],null,{"type":70,"name":75,"description":75,"armGroupLabels":76,"otherNames":73},"Placebo",[9],[78],{"facility":79,"status":73,"city":80,"state":73,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":73},"Charité - Universitätsmedizin Berlin","Berlin","10117","Germany","DE",{"type":85,"coordinates":86},"Point",[87,88],13.41053,52.52437,{"lat":88,"lon":87},{"type":91,"investigatorFullName":73,"investigatorTitle":73,"investigatorAffiliation":73,"oldNameTitle":73,"oldOrganization":73},"SPONSOR","100396667","phase-1-a-study-in-healthy-men-to-test-how-well-different-doses-of-bi-1569912-are-tolerated-and-how-food-influences-the-amount-of-bi-1569912-in-the-blood-100396667",true,"NCT04445090","A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability\u002F Food Effect Part (Open-label, Randomized, Three-way Crossover Design)","Inclusion Criteria:\n\n* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature (T)), 12-lead ECG, and clinical laboratory tests\n* Age of 18 to 45 years (inclusive)\n* BMI of 18.5 to 29.9 kg\u002Fm2 (inclusive)\n* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation\n* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:\n\n  * Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device\n  * Sexually abstinent\n  * Surgically sterilised (including hysterectomy of female partner)\n  * Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U\u002FL and estradiol below 30 ng\u002FL is confirmatory)\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements\n* Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)\n* History of relevant orthostatic hypotension, fainting spells, or any unexplained blackouts\n* Chronic or relevant acute infections\n* A positive polymerase chain reaction (PCR) test for SARS-CoV-2\u002FCOVID-19 and\u002F or any clinical symptom suggestive for this disease at screening and on Day -3.\n\nFurther exclusion criteria apply.","MALE","18 Years","45 Years",{"count":103,"type":104},68,"ACTUAL","INTERVENTIONAL",[107],"PHASE1","SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA\u002FFE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative bioavailability of BI 1569912",[110],"Healthy","TERMINATED","2026-04-29",{"date":114,"type":104},"2026-05-22",{"date":116,"type":104},"2020-07-21",{"date":118,"type":104},"2021-09-10",{"name":5,"class":6},1]