[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07661108":3,"trial-entities:NCT07661108":156,"trial-summary:NCT07661108":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":53,"sex":110,"minimum_age":111,"maximum_age":112,"healthy_volunteers":113,"eligibility_criteria":114,"std_ages":125,"locations":127,"central_contacts":142,"overall_officials":147,"references":151,"see_also_links":152},"NCT07661108","8527-021","A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)","An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants","RECRUITING","2026-10-09","2026-06","2026-07-02","2026-06-30","Merck Sharp & Dohme LLC","INDUSTRY",false,"Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.\n\nThe goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.",null,[19],"Healthy",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"PHASE1",{"count":26,"type":27},44,"ESTIMATED",[29,37,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","MK-8527","Oral tablet",[34,35,36],"Part 1: MK-8527","Part 2: MK-8527 + Probenecid","Part 3: MK-8527 + Itraconazole",{"type":30,"name":38,"description":32,"armGroupLabels":39},"Probenecid",[35],{"type":30,"name":41,"description":42,"armGroupLabels":43},"Itraconazole","Oral solution",[36],[45,49,51],{"measure":46,"description":47,"timeFrame":48},"Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food","Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.","Predose and at designated timepoints (up to 336 hours postdose)",{"measure":50,"description":47,"timeFrame":48},"Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid",{"measure":52,"description":47,"timeFrame":48},"Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole",[54,57,60,63,66,70,73,76,78,80,82,86,89,91,93,95,97,99,102,104,106,108],{"measure":55,"description":56,"timeFrame":48},"Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food","Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.",{"measure":58,"description":59,"timeFrame":48},"Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food","Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.",{"measure":61,"description":62,"timeFrame":48},"Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food","Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.",{"measure":64,"description":65,"timeFrame":48},"Part 1: Apparent Terminal Half-life (t1\u002F2) of MK-8527 in Plasma With and Without Food","Blood samples will be collected to estimate the apparent terminal t1\u002F2 of MK-8527 in plasma.",{"measure":67,"description":68,"timeFrame":69},"Part 1: Number of Participants Who Experience an Adverse Event (AE)","An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.","Up to approximately 43 days",{"measure":71,"description":72,"timeFrame":69},"Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE","An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.",{"measure":74,"description":75,"timeFrame":48},"Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid","Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.",{"measure":77,"description":59,"timeFrame":48},"Part 2: Tmax of MK-8527 in Plasma with and without Probenecid",{"measure":79,"description":62,"timeFrame":48},"Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid",{"measure":81,"description":65,"timeFrame":48},"Part 2: Apparent Terminal t1\u002F2 of MK-8527 in Plasma With and Without Probenecid",{"measure":83,"description":84,"timeFrame":85},"Part 2: Urine Concentration at 72 Hours of MK-8527","Urine samples will be collected to estimate the urine concentration of MK-8527.","At designated timepoints (up to 72 hours postdose)",{"measure":87,"description":88,"timeFrame":85},"Part 2: Renal Clearance of MK-8527","Urine samples will be collected to estimate the renal clearance of MK-8527.",{"measure":90,"description":68,"timeFrame":69},"Part 2: Number of Participants Who Experience an AE",{"measure":92,"description":72,"timeFrame":69},"Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE",{"measure":94,"description":56,"timeFrame":48},"Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole",{"measure":96,"description":59,"timeFrame":48},"Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole",{"measure":98,"description":62,"timeFrame":48},"Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole",{"measure":100,"description":101,"timeFrame":48},"Part 3: Apparent Terminal t1\u002F2 of MK-8527 in Plasma With and Without Itraconazole","Blood samples will be collected to estimate the apparent t1\u002F2 of MK-8527 in plasma.",{"measure":103,"description":84,"timeFrame":85},"Part 3: Urine Concentration at 72 Hours of MK-8527",{"measure":105,"description":88,"timeFrame":85},"Part 3: Renal Clearance of MK-8527",{"measure":107,"description":68,"timeFrame":69},"Part 3: Number of Participants Who Experience an AE",{"measure":109,"description":72,"timeFrame":69},"Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE","ALL","18 Years","55 Years",true,{"inclusion":115,"exclusion":118,"raw_text":124},[116,117],"Be in good health","Has a body mass index (BMI) between 18 and 32 kg\u002Fm\\^2, inclusive",[119,120,121,122,123],"Has an estimated glomerular filtration rate (eGFR) ≤90 mL\u002Fmin\u002F1.73 m\\^2","Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases","Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)","Has a history of cancer (malignancy)","Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)","Inclusion Criteria:\n\n* Be in good health\n* Has a body mass index (BMI) between 18 and 32 kg\u002Fm\\^2, inclusive\n\nExclusion Criteria:\n\n* Has an estimated glomerular filtration rate (eGFR) ≤90 mL\u002Fmin\u002F1.73 m\\^2\n* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)\n* Has a history of cancer (malignancy)\n* Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)",[126],"ADULT",[128],{"facility":129,"status":8,"city":130,"state":131,"zip":132,"country":133,"contacts":134,"geoPoint":139},"Fortrea Clinical Research Unit Inc ( Site 0001)","Daytona Beach","Florida","32117","United States",[135],{"name":136,"role":137,"phone":138},"Study Coordinator","CONTACT","386-366-6400",{"lat":140,"lon":141},29.21081,-81.02283,[143],{"name":144,"role":137,"phone":145,"email":146},"Toll Free Number","1-888-577-8839","Trialsites@msd.com",[148],{"name":149,"affiliation":13,"role":150},"Medical Director","STUDY_DIRECTOR",[],[153],{"label":154,"url":155},"Merck Clinical Trials Information","http:\u002F\u002Fwww.merckclinicaltrials.com",{"nct_id":4,"conditions":157,"biomarkers":159},[158],"Healthy Volunteers",[],{"nct_id":4,"found":113,"summary":161,"prompt_version":171},{"design":162,"status":163,"heading":164,"summary":165,"follow_up":166,"word_count":167,"commitments":168,"compensation":169,"drugs_mentioned":170},"This interventional study plans to enroll 44 healthy participants. It will investigate how MK-8527 interacts with food and other medications.","completed","A Study of MK-8527 in Healthy Adults","This study is looking at a medicine called MK-8527 in healthy adults aged 18 to 55. Researchers want to understand how MK-8527 works in the body when taken with food, or with other medicines like Probenecid or Itraconazole. They will measure how much MK-8527 is in your blood over time. The study also aims to check the safety of MK-8527 and how well people tolerate it. To join, you need to be in good health with a body mass index (BMI) between 18 and 32. The study plans to enroll 44 participants, but its current status is unclear.","Your blood levels of MK-8527 will be measured for up to 336 hours (14 days) after your dose.",98,"You would take MK-8527, Probenecid, or Itraconazole as oral tablets or solution. Blood samples will be taken at specific times up to 336 hours (14 days) after your dose.","Not stated in the trial record.",[31,38,41],"v2"]