[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644214":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":56,"locations":64,"responsibleParty":221,"collaborators":34,"id":223,"slug":224,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":34,"eligibilityCriteria":229,"healthyVolunteers":225,"sex":230,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":34,"studyType":236,"phases":237,"briefSummary":239,"conditions":240,"keywords":34,"overallStatus":67,"whyStopped":34,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Afimkibart Treatment and CYP Cocktail Group","EXPERIMENTAL","Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.",[13,14,15,16,17,18,19],"Drug: Afimkibart","Drug: Caffeine","Drug: Warfarin","Drug: Omeprazole","Drug: Dextromethorphan","Drug: Midazolam","Other: Vitamin K",[21,30,35,39,43,47,51],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Afimkibart","Afimkibart will be administered as per the schedule defined in the protocol.",[9],[27,28,29],"RO7790121","PF-06480605","RVT-3101",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Caffeine","Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.",[9],null,{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Warfarin","Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.",[9],{"type":22,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Omeprazole","Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.",[9],{"type":22,"name":44,"description":45,"armGroupLabels":46,"otherNames":34},"Dextromethorphan","Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.",[9],{"type":22,"name":48,"description":49,"armGroupLabels":50,"otherNames":34},"Midazolam","Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.",[9],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":34},"OTHER","Vitamin K","Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.",[9],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":34,"email":61},"Reference Study ID Number : GA46438 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":63,"role":59,"phone":34,"phoneExt":34,"email":34},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[65,79,89,95,106,115,126,137,146,155,164,173,182,188,192,203,212],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":34},"Erick H. Alayo Medical Corporation - Gastro SB Clinic","RECRUITING","Chula Vista","California","91910","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-117.0842,32.64005,{"lat":77,"lon":76},{"facility":80,"status":67,"city":81,"state":82,"zip":83,"country":71,"countryCode":72,"cosmosGeoPoint":84,"geoPoint":88,"contacts":34},"Allied Biomedical Research Institute, Inc","Miami","Florida","33155",{"type":74,"coordinates":85},[86,87],-80.19366,25.77427,{"lat":87,"lon":86},{"facility":90,"status":67,"city":81,"state":82,"zip":91,"country":71,"countryCode":72,"cosmosGeoPoint":92,"geoPoint":94,"contacts":34},"Gastro Health Research","33176-2416",{"type":74,"coordinates":93},[86,87],{"lat":87,"lon":86},{"facility":96,"status":67,"city":97,"state":34,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":34},"UZ Leuven Gasthuisberg","Leuven","3000","Belgium","BE",{"type":74,"coordinates":102},[103,104],4.70093,50.87959,{"lat":104,"lon":103},{"facility":107,"status":67,"city":108,"state":34,"zip":109,"country":99,"countryCode":100,"cosmosGeoPoint":110,"geoPoint":114,"contacts":34},"AZ Delta (Campus Rumbeke)","Roeselare","8800",{"type":74,"coordinates":111},[112,113],3.12269,50.94653,{"lat":113,"lon":112},{"facility":116,"status":67,"city":117,"state":34,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":34},"Charite Research Organisation GmbH","Berlin","10117","Germany","DE",{"type":74,"coordinates":122},[123,124],13.41053,52.52437,{"lat":124,"lon":123},{"facility":127,"status":67,"city":128,"state":34,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":34},"Centrum Medyczne \"Medis\"","Bydgoszcz","85-229","Poland","PL",{"type":74,"coordinates":133},[134,135],18.00762,53.1235,{"lat":135,"lon":134},{"facility":138,"status":67,"city":139,"state":34,"zip":140,"country":130,"countryCode":131,"cosmosGeoPoint":141,"geoPoint":145,"contacts":34},"Amicare Sp. z o.o. S.K.","Lodz","91-495",{"type":74,"coordinates":142},[143,144],19.47395,51.77058,{"lat":144,"lon":143},{"facility":147,"status":67,"city":148,"state":34,"zip":149,"country":130,"countryCode":131,"cosmosGeoPoint":150,"geoPoint":154,"contacts":34},"Allmedica Badania Kliniczne Sp z o.o. Sp K.","Nowy Targ","34-400",{"type":74,"coordinates":151},[152,153],20.03228,49.47783,{"lat":153,"lon":152},{"facility":156,"status":67,"city":157,"state":34,"zip":158,"country":130,"countryCode":131,"cosmosGeoPoint":159,"geoPoint":163,"contacts":34},"NZOZ Eskulap Pabianice","Pabianice","92-500",{"type":74,"coordinates":160},[161,162],19.35473,51.66446,{"lat":162,"lon":161},{"facility":165,"status":67,"city":166,"state":34,"zip":167,"country":130,"countryCode":131,"cosmosGeoPoint":168,"geoPoint":172,"contacts":34},"SOLUMED Centrum Medyczne","Późna","60-529",{"type":74,"coordinates":169},[170,171],14.61868,51.84442,{"lat":171,"lon":170},{"facility":174,"status":67,"city":175,"state":34,"zip":176,"country":130,"countryCode":131,"cosmosGeoPoint":177,"geoPoint":181,"contacts":34},"Centralny Szpital Kliniczny MSW w Warszawie","Warsaw","02-507",{"type":74,"coordinates":178},[179,180],21.01178,52.22977,{"lat":180,"lon":179},{"facility":183,"status":67,"city":175,"state":34,"zip":184,"country":130,"countryCode":131,"cosmosGeoPoint":185,"geoPoint":187,"contacts":34},"WIP Warsaw IBD Point Profesor Kierkus","04-501",{"type":74,"coordinates":186},[179,180],{"lat":180,"lon":179},{"facility":189,"status":67,"city":190,"state":34,"zip":191,"country":130,"countryCode":131,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"PlanetMed sp. z o.o.","Wroc?aw","52-210",{"facility":193,"status":67,"city":194,"state":34,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":34},"Royal Liverpool University Hospital","Liverpool","L7 8XP","United Kingdom","UK",{"type":74,"coordinates":199},[200,201],-2.97794,53.41058,{"lat":201,"lon":200},{"facility":204,"status":67,"city":205,"state":34,"zip":206,"country":196,"countryCode":197,"cosmosGeoPoint":207,"geoPoint":211,"contacts":34},"University College London Hospitals","London","W1T 7HA",{"type":74,"coordinates":208},[209,210],-0.12574,51.50853,{"lat":210,"lon":209},{"facility":213,"status":67,"city":214,"state":34,"zip":215,"country":196,"countryCode":197,"cosmosGeoPoint":216,"geoPoint":220,"contacts":34},"Royal Victoria Infirmary","Newcastle upon Tyne","NE1 4LP",{"type":74,"coordinates":217},[218,219],-1.61396,54.97328,{"lat":219,"lon":218},{"type":222,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100644214","phase-1-an-early-stage-study-in-multiple-clinics-of-how-afimkibart-may-affect-the-bodys-processing-of-medicines-that-rely-on-cytochrome-p450-enzymes-in-participants-with-ulcerative-colitis-100644214",false,"NCT07665723","An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis","A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Body weight \\>= 40kg\n* Agreement to adhere to the contraceptive requirements\n\nUC Specific Inclusion Criteria:\n\n* Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence\n* Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending \\>=15 cm from the anal verge\n* Moderately to severely active UC, defined as an modified Mayo score of 5 to 9 points, including a Mayo endoscopic subscore of 2 or 3, confirmed through centrally read endoscopy\n\nExclusion Criteria:\n\nInflammatory Bowel Disease (IBD) Exclusion Criteria:\n\n* Current diagnosis of Crohn's disease (CD),abdominal\u002Fintrabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n\nMedical History Exclusion Criteria:\n\n* Lack of peripheral venous access\n* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study\n* History of alcohol, drug, or chemical abuse \\\u003C 1 year prior to screening","ALL","18 Years","60 Years",{"count":234,"type":235},25,"ESTIMATED","INTERVENTIONAL",[238],"PHASE1","The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).",[241],"Active Ulcerative Colitis","2026-08-19",{"date":244,"type":245},"2026-08-20","ACTUAL",{"date":247,"type":245},"2026-06-29",{"date":249,"type":235},"2030-12-31",{"name":5,"class":6},17]