[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558708":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":27,"locations":44,"responsibleParty":58,"collaborators":27,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":27,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":27,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"MK-5684 Period 1","EXPERIMENTAL","On Day 1 a single dose of MK-5684 will be administered under fasting conditions and a single dose of HRT (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after MK-5684 dosing.",[13,14,15],"Drug: MK-5684","Drug: Prednisone","Drug: Fludrocortisone acetate",{"label":17,"type":10,"description":18,"interventionNames":19},"MK-5684 Period 2","There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and\u002For diltiazem dosing.",[13,14,15,20],"Drug: Diltiazem hydrocholoride",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","MK-5684","Administered via oral tablet per dosing regimen.",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Prednisone","Administered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets.",[9,17],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Fludrocortisone acetate","Administered at a dose of 0.05 mg per HRT dosing regimen via oral tablets.",[9,17],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Diltiazem hydrocholoride","Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release).",[17],[41],{"name":42,"affiliation":5,"role":43},"Medical Director","STUDY_DIRECTOR",[45],{"facility":46,"status":27,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":27},"Celerion ( Site 0001)","Tempe","Arizona","85283","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-111.90931,33.41477,{"lat":56,"lon":55},{"type":59,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100558708","phase-1-a-drug-drug-interaction-study-of-diltiazem-and-mk-5684-in-healthy-adult-male-participants-mk-5684-011-100558708",false,"NCT06554639","A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)","A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Diltiazem 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* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting\n* Body mass index (BMI) ≥18.0 and ≤32.0 kg\u002Fm\\^2\n* Able to swallow multiple tablets\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History or presence of any of the following:\n\n  * Adrenal insufficiency\n  * Hepatic or renal impairment\n  * Clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events\n  * Second- or third-degree Atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker)\n  * Clinically significant sick sinus syndrome\n  * Presence of any systemic fungal infection\n  * Chronic infection\n  * Glaucoma\n  * Hypothyroidism\n  * Stomach ulcer\n  * Ocular herpes simplex\n* Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)\n* History of cancer (malignancy)\n* Unable to refrain from or anticipants the use of: Unable to refrain from or anticipates the use of: Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing",true,"MALE","18 Years","55 Years",{"count":72,"type":73},12,"ACTUAL","INTERVENTIONAL",[76],"PHASE1","Researchers have designed a study medicine called MK-5684 as a new way to treat prostate cancer.\n\nThe purpose of this study is to learn what happens to MK-5684 in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to MK-5684 in the body when it is given with and without another medicine called diltiazem.",[79],"Prostatic Neoplasms","COMPLETED","2024-10-10",{"date":83,"type":73},"2024-10-15",{"date":85,"type":73},"2024-07-11",{"date":87,"type":73},"2024-08-29",{"name":5,"class":6},1]