[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644825":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":60,"collaborators":33,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":33,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":33,"overallStatus":82,"whyStopped":33,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},{"fullName":5,"class":6},"Agomab Therapeutics NV","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Ontunisertib","EXPERIMENTAL","Participants will receive single oral dose of ontunisertib",[13],"Drug: Ontunisertib",{"label":15,"type":10,"description":16,"interventionNames":17},"[14C]ontunisertib solution for infusion","Participants will receive single IV dose of \\[14C\\]ontunisertib",[18],"Drug: [14C]ontunisertib",{"label":20,"type":10,"description":21,"interventionNames":22},"[14C]ontunisertib","Participants will receive single oral dose of \\[14C\\]ontunisertib",[18],[24,30,34],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Oral capsule",[9],[29],"AGMB-129",{"type":25,"name":20,"description":31,"armGroupLabels":32,"otherNames":33},"IV infusion",[15],null,{"type":25,"name":20,"description":26,"armGroupLabels":35,"otherNames":33},[20],[37],{"name":38,"affiliation":39,"role":40},"Silke Hüttner, MD","Agomab Therapeutics","STUDY_DIRECTOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":33,"email":46},"Agomab Clinical Operations","CONTACT","0032 3318 91 70","clinicalstudies@agomab.com",[48],{"facility":49,"status":33,"city":50,"state":33,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":33},"Quotient Sciences Limited","Nottingham","NG11 6JS","United Kingdom","UK",{"type":55,"coordinates":56},"Point",[57,58],-1.15047,52.9536,{"lat":58,"lon":57},{"type":61,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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":74,"type":75},8,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81],"Fibrostenotic Crohn's Disease","NOT_YET_RECRUITING","2026-06-22",{"date":85,"type":86},"2026-06-29","ACTUAL",{"date":88,"type":75},"2026-07-20",{"date":90,"type":75},"2026-12-31",{"name":92,"class":6},"Agomab Spain S.L.U.",1]