[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518278":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":27,"locations":28,"responsibleParty":41,"collaborators":27,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":27,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":27,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":27,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Zongertinib Alone (Reference)\u002F Zongertinib+Carbamazepine (Test)","EXPERIMENTAL","Participants took a single 60 mg oral dose of Zongertinib after fasting overnight (reference period). In the test period, they took the same Zongertinib dose after 18 days of daily Carbamazepine pretreatment, with doses increasing from 200 mg to 600 mg. They continued taking 600 mg of Carbamazepine daily for 6 days after the Zongertinib dose.",[13,14],"Drug: Zongertinib","Drug: Carbamazepine",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Zongertinib","Participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours.",[9],[22],"Hernexeos®",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Carbamazepine","Participants received increasing doses of Carbamazepine once daily as extended-release tablets with 240 mL of water for 18 days, starting at 200 mg, then 400 mg, and finally 600 mg. Afterward, they continued taking 600 mg of Carbamazepine once daily for 6 days.",[9],null,[29],{"facility":30,"status":27,"city":31,"state":27,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":27},"CRS Clinical Research Services Mannheim GmbH","Mannheim","68167","Germany","DE",{"type":36,"coordinates":37},"Point",[38,39],8.46694,49.4891,{"lat":39,"lon":38},{"type":42,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100518278","phase-1-a-study-in-healthy-men-to-test-whether-carbamazepine-influences-the-amount-of-zongertinib-in-the-blood-100518278",true,"NCT06028464","A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood","The Effect of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)","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)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests\n* Age of 18 to 55 years (inclusive)\n* Body mass index (BMI) of 18.5 to 29.9 kg\u002Fm2 (inclusive)\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including BP, PR or ECG, the neurological examination, or the skin inspection) 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\n* Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts\n* Further exclusion criteria apply","MALE","18 Years","55 Years",{"count":54,"type":55},16,"ACTUAL","INTERVENTIONAL",[58],"PHASE1","The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in plasma.",[61],"Healthy","COMPLETED","2025-10-14",{"date":65,"type":55},"2025-11-05",{"date":67,"type":55},"2023-09-11",{"date":69,"type":55},"2023-12-08",{"name":5,"class":6},1]