[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559657":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":40,"locations":41,"responsibleParty":55,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":40,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":40,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":40,"overallStatus":80,"whyStopped":40,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[¹⁴C]Opevesostat","EXPERIMENTAL","On Day 1, participants receive a single dose of \\[¹⁴C\\]opevesostat as an oral solution. Participants then receive single doses of 5.0 mg prednisone and 0.05 mg fludrocortisone tablets 4 hours later as hormone replacement therapy.",[13,14,15],"Drug: [¹⁴C]Opevesostat","Drug: Prednisone","Drug: Fludrocortisone",[17,23,31],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Oral solution",[9],[22],"MK-5684",{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Prednisone","Tablet",[9],[28,29,30],"RAYOS®","STERAPRED®","DELTASONE®",{"type":18,"name":32,"description":25,"armGroupLabels":33,"otherNames":34},"Fludrocortisone",[9],[35],"FLORINEF®",[37],{"name":38,"affiliation":5,"role":39},"Medical Director","STUDY_DIRECTOR",null,[42],{"facility":43,"status":40,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":40},"Quotient Sciences ( Site 0001)","Nottingham","Nottinghamshire","NG11 6JS","United Kingdom","UK",{"type":50,"coordinates":51},"Point",[52,53],-1.15047,52.9536,{"lat":53,"lon":52},{"type":56,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[58],{"name":59,"class":6},"Orion Corporation, Orion Pharma","100559657","phase-1-a-study-of-the-absorption-distribution-metabolism-and-elimination-of-opevesostat-mk-5684-in-healthy-adult-male-participants-mk-5684-008-100559657",false,"NCT06566989","A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)","An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-5684 in Healthy Male Participants","Inclusion Criteria:\n\n* Is a healthy male according to the assessment of the investigator\n* Has a body mass index of 18.0 to 32.0 kg\u002Fm2\n* Has regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)\n\nExclusion Criteria:\n\n* Has the presence or history of clinically significant allergy requiring treatment\n* Has a history of adrenal insufficiency\n* Has veins not suitable for multiple venipunctures\u002Fcannulation\n* Has previously taken part in more than 3 radiolabeled drug studies in the last 12 months\n* Has donated blood or plasma within the previous 3 months or lost greater than 400 mL of blood",true,"MALE","30 Years","55 Years",{"count":72,"type":73},8,"ACTUAL","INTERVENTIONAL",[76],"PHASE1","This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics (PK), metabolic profile, and safety and tolerability.",[79],"Metastatic Prostate Cancer","COMPLETED","2024-10-22",{"date":83,"type":73},"2024-10-23",{"date":85,"type":73},"2024-09-19",{"date":87,"type":73},"2024-10-17",{"name":5,"class":6},1]