[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635124":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":34,"locations":46,"responsibleParty":60,"collaborators":34,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":34,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":34,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":34,"overallStatus":82,"whyStopped":34,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Opevesostat Period 1","EXPERIMENTAL","On Day 1, a single dose of opevesostat will be administered under fed conditions. A single dose of steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.",[13,14,15],"Drug: Opevesostat","Drug: Prednisone","Drug: Fludrocortisone acetate",{"label":17,"type":10,"description":18,"interventionNames":19},"Opevesostat Period 2","There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, itraconazole will be administered once daily (QD) for 9 consecutive days with a single dose of opevesostat coadministered on Day 4 under fed conditions. Steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 4 through 6, approximately 4.5 hours after opevesostat and\u002For itraconazole dosing.",[13,14,15,20],"Drug: Itraconazole",[22,30,35,38],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Opevesostat","Administered via oral film-coated tablet",[9,17],[28,29],"MK-5684","ODM-208",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Prednisone","Administered via oral tablet",[9,17],null,{"type":23,"name":36,"description":32,"armGroupLabels":37,"otherNames":34},"Fludrocortisone acetate",[9,17],{"type":23,"name":39,"description":40,"armGroupLabels":41,"otherNames":34},"Itraconazole","Administered via oral capsule",[17],[43],{"name":44,"affiliation":5,"role":45},"Medical Director","STUDY_DIRECTOR",[47],{"facility":48,"status":34,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":34},"Celerion, Inc. ( Site 0001)","Lincoln","Nebraska","68502","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-96.66696,40.8,{"lat":58,"lon":57},{"type":61,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100635124","phase-1-a-drug-drug-interaction-study-of-itraconazole-and-opevesostat-mk-5684-in-healthy-adult-male-participants-mk-5684-017-100635124",false,"NCT07548606","A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017)","A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a body mass index ≥18.0 and ≤32.0 kg\u002Fm\\^2\n* Is medically healthy with no clinically significant medical history\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history or presence of any of the following: adrenal insufficiency; hepatic or renal impairment; clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events; second- or third-degree atrioventricular heart block; clinically significant sick sinus syndrome; any systemic fungal infection; chronic infection; glaucoma; hypothyroidism; stomach ulcer; ocular herpes simplex; ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)\n* Has a history of cancer (malignancy)",true,"MALE","19 Years","55 Years",{"count":74,"type":75},14,"ACTUAL","INTERVENTIONAL",[78],"PHASE1","Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.\n\nThe purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called itraconazole.",[81],"Healthy","COMPLETED","2026-06-24",{"date":85,"type":75},"2026-06-25",{"date":87,"type":75},"2026-05-11",{"date":89,"type":75},"2026-06-18",{"name":5,"class":6},1]