[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602031":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":11,"studyPopulation":11,"armGroups":47,"interventions":65,"overallOfficials":84,"centralContacts":88,"locations":96,"responsibleParty":115,"collaborators":11,"id":117,"slug":11,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":11,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":11,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,15,17,19,21],{"measure":10,"description":11,"timeFrame":12},"Part 1\u002F1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT",null,"Up to approximately day 24",{"measure":14,"description":11,"timeFrame":12},"Part 1\u002F1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT",{"measure":16,"description":11,"timeFrame":12},"Part 2: GMR of Cmax of fexofenadine with and without KarXT",{"measure":18,"description":11,"timeFrame":12},"Part 2: GMR of AUC of fexofenadine with and without KarXT",{"measure":20,"description":11,"timeFrame":12},"Part 3: GMR of Cmax of digoxin with and without KarXT",{"measure":22,"description":11,"timeFrame":12},"Part 3: GMR of AUC of digoxin with and without KarXT",[24,27,29,31,33,35,37,39],{"measure":25,"description":11,"timeFrame":26},"Number of participants with adverse events (AEs)","Up to approximately day 47",{"measure":28,"description":11,"timeFrame":26},"Number of participants with serious adverse events (SAEs)",{"measure":30,"description":11,"timeFrame":12},"Number of participants with physical examination abnormalities",{"measure":32,"description":11,"timeFrame":12},"Number of participants with vital sign abnormalities",{"measure":34,"description":11,"timeFrame":12},"Number of participants with 12-lead electrocardiogram abnormalities (ECGs)",{"measure":36,"description":11,"timeFrame":12},"Number of participants with clinical laboratory assessment abnormalities",{"measure":38,"description":11,"timeFrame":12},"Number of participants with suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)",{"measure":40,"description":11,"timeFrame":26},"Number of participants with adverse event of special interest (AESIs)",{"allocation":42,"interventionModel":43,"interventionModelDescription":11,"primaryPurpose":44,"observationalModel":11,"timePerspective":11,"maskingInfo":45},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":11,"whoMasked":11},"NONE",[48,54,58,62],{"label":49,"type":50,"description":11,"interventionNames":51},"Part 1","EXPERIMENTAL",[52,53],"Drug: KarXT","Drug: Midazolam",{"label":55,"type":50,"description":11,"interventionNames":56},"Part 2",[52,57],"Drug: Fexofenadine",{"label":59,"type":50,"description":11,"interventionNames":60},"Part 3",[52,61],"Drug: Digoxin",{"label":63,"type":50,"description":11,"interventionNames":64},"Part 1a",[52,53],[66,75,78,81],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DRUG","KarXT","Specified dose on specified days",[49,63,55,59],[72,73,74],"BMS-986510","Xanomeline","Trospium Chloride",{"type":67,"name":76,"description":69,"armGroupLabels":77,"otherNames":11},"Midazolam",[49,63],{"type":67,"name":79,"description":69,"armGroupLabels":80,"otherNames":11},"Fexofenadine",[55],{"type":67,"name":82,"description":69,"armGroupLabels":83,"otherNames":11},"Digoxin",[59],[85],{"name":86,"affiliation":86,"role":87},"Bristol-Myers Squibb","STUDY_DIRECTOR",[89,94],{"name":90,"role":91,"phone":92,"phoneExt":11,"email":93},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":95,"role":91,"phone":11,"phoneExt":11,"email":11},"First line of the email MUST contain NCT # and Site #.",[97],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"ICON - Lenexa","RECRUITING","Lenexa","Kansas","66219-9746","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-94.73357,38.95362,{"lat":109,"lon":108},[112],{"name":113,"role":91,"phone":114,"phoneExt":11,"email":11},"Patrick Yao, Site 0001","913-410-2674",{"type":116,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100602031",false,"NCT07118215","A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin","A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants","Inclusion Criteria:\n\n* Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.\n* Participants must have BMI of 18.0 to 32.0 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.\n* Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and\u002For active hepatic viral infections based on the LFT results.\n* Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.\n* Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.\n* Participants must not have current or recent (within 3 months of first study intervention administration) GI disease that could possibly affect drug ADME (eg, bariatric procedure).\n* Participants must not have any major surgery, including GI surgery (eg, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).\n* Participants must not have history of active GI obstructive disorder.\n* Participants must not have history of bladder stones.\n* Participants must not have history of recurrent urinary tract infections.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,"ALL","18 Years","50 Years",{"count":128,"type":129},60,"ESTIMATED","INTERVENTIONAL",[132],"PHASE1","The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.",[135],"Healthy Volunteers",[137,138,72,68,139,76,79,82,140],"Healthy volunteer","Pharmacokinetics","Cobenfy","Drug-drug interaction","2026-06-10",{"date":143,"type":144},"2026-06-11","ACTUAL",{"date":146,"type":144},"2025-09-29",{"date":148,"type":129},"2026-06-25",{"name":5,"class":6},1]