[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658809":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":35,"armGroups":42,"interventions":51,"overallOfficials":35,"centralContacts":70,"locations":77,"responsibleParty":92,"collaborators":35,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":35,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":35,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":35,"overallStatus":80,"whyStopped":35,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":35},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"AUC for digoxin and rosuvastatin","area under curve","Up to Day 13 in Period 2",{"measure":14,"description":15,"timeFrame":12},"AUClast for digoxin and rosuvastatin","area under the curve from time zero to the last measurable concentration",{"measure":17,"description":18,"timeFrame":12},"Cmax for digoxin and rosuvastatin","maximum (peak) plasma concentration",[20,23,26,28,31],{"measure":21,"description":22,"timeFrame":12},"tmax for digoxin and for rosuvastatin","time to reach maximum plasma concentration",{"measure":24,"description":22,"timeFrame":25},"tmax for rilzabrutinib","Up to Day 11 in Period 2",{"measure":27,"description":18,"timeFrame":25},"Cmax for rilzabrutinib",{"measure":29,"description":30,"timeFrame":25},"AUC0-tau for rilzabrutinib","area under the plasma concentration-time curve from time 0 to tau",{"measure":32,"description":33,"timeFrame":34},"Assessment of AEs and TEAEs","including clinical laboratory evaluation, vital signs, and electrocardiogram (ECG).","Up to Day 21 in Period 2",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"Treatment A then Treatment B","EXPERIMENTAL","Treatment A in Period 1: digoxin + rosuvastatin cocktail alone on Day 1 of Period 1 Treatment B in Period 2: rilzabrutinib (SAR444671) BID from Day 1 to Day 12 of Period 2, plus digoxin + rosuvastatin cocktail on Day 8 of Period 2",[48,49,50],"Drug: Rilzabrutinib","Drug: Rosuvastatin","Drug: Digoxin",[52,59,65],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Rilzabrutinib","From Day 1 to Day 12 of Period 2",[44],[58],"SAR444671",{"type":53,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Rosuvastatin","Single dose on Day 1 of Period 1 and on Day 8 of Period 2",[44],[64],"Crestor",{"type":53,"name":66,"description":61,"armGroupLabels":67,"otherNames":68},"Digoxin",[44],[69],"Lanicor",[71],{"name":72,"role":73,"phone":74,"phoneExt":75,"email":76},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":35},"Investigational Site Number : 1240001","RECRUITING","Québec","Quebec","G1P 0A2","Canada","CA",{"type":87,"coordinates":88},"Point",[89,90],-71.21454,46.81228,{"lat":90,"lon":89},{"type":93,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100658809","phase-1-an-open-label-ddi-study-to-investigate-the-effect-of-rilzabrutinib-on-p-gp-bcrp-oatp1b1-and-oatp1b3-inhibition-100658809",false,"NCT07855250","An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition","A Phase-1, Open-label, One-sequence, Two-treatment Period, Cross-over, Drug-drug Interaction Study to Evaluate the Effect of Oral Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Substrates in Healthy Participants","Inclusion Criteria\n\n* Participant must be 18 to 55 years of age inclusive.\n* Body weight between 50.0 and 100.0 kg for males, 40.0 and 90.0 kg for females.\n* Contraceptive use by male and female participants should be consistent with local regulations\n\nExclusion Criteria\n\n* History of serious infections requiring intravenous therapy.\n* Frequent headaches, migraine, nausea or vomiting.\n* Blood donation within 1 month before inclusion.\n* History of drug hypersensitivity or allergic disease.\n* History of drug or alcohol abuse.\n* Smoking regularly more than 5 cigarettes or equivalent in nicotine per week\n* Excessive consumption of beverages containing xanthine bases.\n* Pregnancy or breastfeeding.\n* Recent vaccinations.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",true,"ALL","18 Years","55 Years",{"count":106,"type":107},14,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","The study is a single-center, Phase-1, open-label, one-sequence, two-treatment period, cross-over, DDI study designed to investigate the effects of rilzabrutinib on the PK of digoxin (as P-gp substrate) and of rosuvastatin (as substrate of BCRP, OATP1B1, and OATP1B3) in healthy male and female participants. For this study a cocktail of digoxin and rosuvastatin will be used.",[113],"Healthy Volunteer","2026-09-27",{"date":116,"type":117},"2026-10-02","ACTUAL",{"date":119,"type":107},"2026-10-01",{"date":121,"type":107},"2026-11-03",{"name":5,"class":6},1]