[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650263":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":22,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":22,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":22,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":82,"whyStopped":22,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fixed-Sequence treatment","EXPERIMENTAL","All participants will receive dabigatran alone and rosuvastatin alone in Treatment Period 1. During Treatment Period 2, participants will receive CHF10196 alone, with dabigatran, and with rosuvastatin.",[13,14,15],"Drug: Dabigatran Etexilate","Drug: Rosuvastatin","Drug: CHF10196",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Dabigatran Etexilate","Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Rosuvastatin","Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"CHF10196","Treatment period 2: Single dose administered daily from Day 8 to Day 19",[9],[32],{"name":33,"affiliation":34,"role":35},"Jonathan Ackroyd","Fortrea Clinical Research Unit (CRU)","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":22,"email":41},"Chiesi Clinical Trial Info","CONTACT","+39 0521 279 715","Clinicaltrials_info@chiesi.com",[43],{"facility":44,"status":22,"city":45,"state":22,"zip":22,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fortrea Clinical Research Unit (CRU) Limited","Leeds","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-1.54785,53.79648,{"lat":52,"lon":51},[55],{"name":33,"role":39,"phone":22,"phoneExt":22,"email":22},{"type":57,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100650263","phase-1-a-study-in-healthy-male-participants-to-compare-how-chf10196-affects-how-the-body-absorbs-and-processes-two-commonly-used-medicines-dabigatran-a-blood-thinner-and-rosuvastatin-a-medicine-used-to-lower-cholesterol-100650263",false,"NCT07744386","A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol","An Open-label, Fixed-sequence, Non-randomized, Drug-drug Interaction Study to Evaluate the Effect of CHF10196 on the Pharmacokinetics of Dabigatran (P-gp Substrate) and Rosuvastatin (BCRP Substrate) in Healthy Male Participants.","Inclusion Criteria:\n\n* Healthy male participants aged 18 to 55 years\n* Body mass index between 18.0 and 30.0 kg\u002Fm²\n* Non-smokers or ex-smokers (\\\u003C5 pack-years)\n* Clinically healthy based on medical history and examination\n* Vital signs and ECG within normal limits\n* Willing and able to comply with study procedures\n\nExclusion Criteria:\n\n* Use of prohibited concomitant medications\n* Participation in another clinical study within 3 months\n* Clinically relevant medical conditions\n* Abnormal laboratory values\n* Positive HIV, hepatitis B, or hepatitis C\n* History of bleeding disorders\n* Drug or alcohol abuse\n* Use of nicotine-containing products within defined period\n* Recent COVID-19 infection",true,"MALE","18 Years","55 Years",{"count":70,"type":71},24,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a breast cancer resistant protein substrate) in healthy male participants.",[77],"Healthy Male Volunteers",[79,28,80,81],"pharmacokinetics","DDI","Dipeptidyl Peptidase 1 (DPP1) inhibitor","NOT_YET_RECRUITING","2026-07-29",{"date":85,"type":86},"2026-08-04","ACTUAL",{"date":88,"type":71},"2026-10-27",{"date":90,"type":71},"2028-12-15",{"name":5,"class":6},1]