[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656081":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":50,"overallOfficials":68,"centralContacts":72,"locations":77,"responsibleParty":92,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":27,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":27,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":27,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":27},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)","AUC0-inf for midazolam, celecoxib, dabigatran, and rosuvastatin.","Samples will be collected predose and at specified timepoints, up to 10 days",{"measure":14,"description":15,"timeFrame":12},"Area Under the Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast)","AUC0-tlast for midazolam, celecoxib, dabigatran, and rosuvastatin.",{"measure":17,"description":18,"timeFrame":12},"Maximum Observed Concentration (Cmax)","Cmax for midazolam, celecoxib, dabigatran, and rosuvastatin.",{"measure":20,"description":21,"timeFrame":12},"Time to Reach Maximum Observed Concentration (Tmax)","Tmax for midazolam, celecoxib, dabigatran, and rosuvastatin.",[23],{"measure":24,"description":25,"timeFrame":26},"Number of Participants With Adverse Events (AEs)","Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), clinical laboratory abnormalities, 12-lead electrocardiogram, vital signs measurement, and physical examination findings.","From first dose up to 17 days",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","BGB-43395 is a drug that blocks a protein called cyclin-dependent kinase 4 (CDK4). CDK4 is a type of protein that regulates cell growth and division and can drive uncontrolled tumor cell growth. BGB-43395 is being developed for the treatment of patients with advanced solid tumors.\n\nThe purpose of this study is to test whether BGB-43395 has any significant drug interactions with midazolam, celecoxib, dabigatran, and rosuvastatin. The main goal of the study is to test whether BGB-43395 affects how other drugs are processed by the body.\n\nThis study consists of 2 parts. In Part 1, healthy participants will receive midazolam and celecoxib alone and with BGB-43395. In Part 2, healthy participants will receive dabigatran and rosuvastatin alone and with BGB-43395.\n\nThe study will enroll approximately 24 healthy adult participants. The overall time to participate in this study is up to 7 weeks. Blood samples will be taken at specific time points, as well as vital signs and electrocardiograms.",[36,44],{"label":37,"type":38,"description":39,"interventionNames":40},"Part 1","EXPERIMENTAL","Participants will receive midazolam and celecoxib alone and with BGB-43395.",[41,42,43],"Drug: BGB-43395","Drug: Midazolam","Drug: Celecoxib",{"label":45,"type":38,"description":46,"interventionNames":47},"Part 2","Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.",[41,48,49],"Drug: Dabigatran etexilate","Drug: Rosuvastatin",[51,56,59,62,65],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":27},"DRUG","BGB-43395","Administered orally",[37,45],{"type":52,"name":57,"description":54,"armGroupLabels":58,"otherNames":27},"Midazolam",[37],{"type":52,"name":60,"description":54,"armGroupLabels":61,"otherNames":27},"Celecoxib",[37],{"type":52,"name":63,"description":54,"armGroupLabels":64,"otherNames":27},"Dabigatran etexilate",[45],{"type":52,"name":66,"description":54,"armGroupLabels":67,"otherNames":27},"Rosuvastatin",[45],[69],{"name":70,"affiliation":5,"role":71},"Study Director","STUDY_DIRECTOR",[73],{"name":70,"role":74,"phone":75,"phoneExt":27,"email":76},"CONTACT","877-828-5568","clinicaltrials@beonemed.com",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":27},"Fortrea CRU","RECRUITING","Dallas","Texas","75247","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-96.80667,32.78306,{"lat":90,"lon":89},{"type":93,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[95],{"name":96,"class":6},"Fortrea","100656081","phase-1-a-trial-in-healthy-participants-to-assess-drug-interaction-potential-of-bgb-43395-100656081",false,"NCT07820891","A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395","A Phase 1, Open-label, Fixed-sequence Trial in Healthy Participants to Assess the Drug Interaction Potential of BGB-43395 With A Drug Cocktail Representative for CYP3A4, CYP2C9, P-gp, and BCRP Substrates","Inclusion Criteria:\n\n* Body mass index between 18.0 and 32.0 kg\u002Fm\\^2, inclusive.\n* In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram and vital signs measurements, and clinical laboratory assessments.\n* Participants must not be pregnant or lactating and must agree to use contraception.\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs\n* Confirmed systolic blood pressure \\>140 or \\\u003C90 mmHg, diastolic blood pressure \\>90 or \\\u003C50 mmHg, or pulse rate \\>100 or \\\u003C40 beats per minute.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",true,"ALL","18 Years","65 Years",{"count":109,"type":110},24,"ESTIMATED","INTERVENTIONAL",[113],"PHASE1","This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.",[116],"Healthy Adult Participants","2026-10-05",{"date":119,"type":120},"2026-10-08","ACTUAL",{"date":122,"type":120},"2026-09-25",{"date":124,"type":110},"2026-11-22",{"name":5,"class":6},1]