[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100303994":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":22,"locations":35,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":22,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":22,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":76,"whyStopped":22,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BAY1841788\u002FHealthy subjects","EXPERIMENTAL","Period 1: intake of Midazolam and Dabigatran etexilate at day 1 followed by Period 2: intake of Darolutamide at days 1-11 (twice daily), intake of dabigatran etexilate at days 3 and 9, intake of Midazolam at day 9",[13,14,15],"Drug: Dabigatran etexilate","Drug: Midazolam","Drug: BAY1841788 (darolutamide)",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Dabigatran etexilate","In Period 1, Day 1 a single dose of 75 mg will be administered after breakfast In Period 2, Day 3 a single dose of 75 mg will be administered prior to breakfast In Period 2, Day 9 a single dose of 75 mg will be administered after breakfast",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Midazolam","In Period 1, Day 1 a single dose of 1 mg will be administered after breakfast In Period 2, Day 9 a single dose of 1 mg will be administered after breakfast",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"BAY1841788 (darolutamide)","In Period 2, Days 1-11 600 mg twice a day (as 2 x 300 mg tablets) will be administered after breakfast",[9],[32],{"name":33,"affiliation":5,"role":34},"Bayer Study Director","STUDY_DIRECTOR",[36],{"facility":37,"status":22,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":22},"CRS Clinical-Research-Services Mannheim GmbH","Mannheim","Baden-Wurttemberg","68167","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],8.46694,49.4891,{"lat":47,"lon":46},{"type":50,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[52],{"name":53,"class":6},"Orion Corporation, Orion Pharma","100303994","phase-1-drug-drug-interaction-study-to-assess-the-effect-of-darolutamide-on-the-pharmacokinetics-of-probe-substrates-of-cyp3a4-and-p-gp-in-healthy-male-volunteers-100303994",false,"NCT03237416","Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers","A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of Darolutamide (ODM-201) on the Pharmacokinetics of a Probe Substrate of CYP3A4 and P-gp in Healthy Male Volunteers","Inclusion Criteria:\n\n* Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring.\n* Gender: Male.\n* Age: 45 to 65 years (inclusive) at the screening visit.\n* Race: White.\n* Body mass index (BMI): ≥18.0 and ≤30.0 kg\u002Fm2.\n* Agree to use condoms as an effective contraception barrier method and refrain from sperm donation during the whole study (starting after informed consent) and for 3 months after the end of treatment with darolutamide.\n\nIn addition, participants must agree to utilize a second reliable method of contraception simultaneously. The second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception. Therefore, contraception methods to be used by male subjects and female partners are in line with clinical trial facilitation group recommendations related to contraception in clinical trials.\n\n* Ability to understand and follow study-related instructions.\n* Results of alcohol tests are negative at screening and on Study Day -1.\n* Confirmation of the subject's health insurance coverage prior to the first screening examination\u002Fvisit.\n\nExclusion Criteria:\n\n* Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).\n* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n* Known history of hypersensitivity (or known allergic reaction) to medications including any ingredient of midazolam, benzodiazepines, dabigatran etexilate, or darolutamide.\n* Relevant hepatic disorders like cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.\n* Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation.\n* CYP3A4 inhibitors within 1 week or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.\n* CYP3A4 inducers as well as St John's Wort within 28 days or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.\n* Known BCRP and OATP substrates within 28 days or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.\n* P-gp inducers (e.g. rifampin) within 28 days or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.\n* P-gp inhibitors within 1 week or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.",true,"MALE","45 Years","65 Years",{"count":66,"type":67},15,"ACTUAL","INTERVENTIONAL",[70],"PHASE1","Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and Pgp substrate",[73],"Prostatic Neoplasms",[75],"Drug-drug interaction","COMPLETED","2018-11-05",{"date":79,"type":67},"2018-11-06",{"date":81,"type":67},"2017-08-02",{"date":83,"type":67},"2017-12-18",{"name":5,"class":6},1]