[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Agomab Spain S.L.U.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100644825","phase-1-human-mass-balance-study-of-14c-ontunisertib-in-healthy-volunteers-100644825",false,"NCT07672574","Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers","An Open-label, Two-part Trial to Assess the Mass-balance Recovery, Metabolite Profile, Metabolite Identification and Absolute Bioavailability of [14C] Ontunisertib in Healthy Male Participants","Inclusion Criteria:\n\n* Males aged 30 to 65 years inclusive at the time of signing informed consent\n* Must agree to the use of an adequate method of contraception for up to 93 days post-final dose\n* Healthy male participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities.\n* Body mass index of 18.0 to 29.9 kg\u002Fm2\n\nExclusion Criteria:\n\n* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients\n* History of clinically significant renal, hepatic, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, and neurological or psychiatric disorder\n* History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)\n* Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening.\n* Radiation exposure, including that from the present trial, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the trial\n* Participants who have been administered IMP in an ADME trial or any trial involving administration of 14C radioactivity in the last 12 months\n* Male participants with pregnant or lactating partners",true,"MALE","30 Years","65 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is an open, two-part study in healthy male volunteers, aged 30-65 years.\n\nThis trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine (\\[14C\\]ontunisertib) and determine the routes and rates of elimination of the test medicine.",[28],"Fibrostenotic Crohn's Disease","NOT_YET_RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":22},"2026-07-20",{"date":37,"type":22},"2026-12-31",{"name":39,"class":40},"Agomab Spain S.L.U.","INDUSTRY",""]