[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07528508":3,"trial-entities:NCT07528508":106,"trial-summary:NCT07528508":110},{"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":39,"secondary_outcomes":47,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":82,"locations":85,"central_contacts":95,"overall_officials":96,"references":101,"see_also_links":102},"NCT07528508","8527-020","A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527-020)","A Clinical Trial to Study the Effect of a Single Dose of MK-8527 on the Pharmacokinetics of Methadone","COMPLETED","2026-07-31","2026-08","2026-08-26","2026-05-22","Merck Sharp & Dohme LLC","INDUSTRY",false,"The goal of this study is to learn about the effect of a study medicine called MK-8527 when taken with methadone. The study will also measure what happens to the methadone in a healthy person's body over time after MK-8527 is taken.",null,[19],"Healthy",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"PHASE1",{"count":26,"type":27},14,"ACTUAL",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","MK-8527","Tablet for oral administration.",[34],"Methadone + MK-8527",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Methadone","Formulated per local guidelines, administered orally.",[34],[40,44],{"measure":41,"description":42,"timeFrame":43},"Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone","The dose-normalized AUC0-24hr of R-methadone will be determined on Day 1.","Up to 24 hours",{"measure":45,"description":46,"timeFrame":43},"Dose-Normalized AUC0-24 of S-Methadone","The dose-normalized AUC0-24hr of S-methadone will be determined on Day 1.",[48,52,55,58,61,65],{"measure":49,"description":50,"timeFrame":51},"Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone","The dose-normalized Cmax of R-methadone will be determined on Day 1.","Up to approximately 2 weeks",{"measure":53,"description":54,"timeFrame":51},"Dose-Normalized Cmax of S-Methadone","The dose-normalized Cmax of S-methadone will be determined on Day 1.",{"measure":56,"description":57,"timeFrame":43},"Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone","The dose normalized C24hr of R-methadone will be determined on Day 1.",{"measure":59,"description":60,"timeFrame":43},"Dose-Normalized C24 of S-Methadone","The dose-normalized C24hr of S-methadone will be determined on Day 1.",{"measure":62,"description":63,"timeFrame":64},"Number of Participants Who Experience an Adverse Event (AE)","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.","Up to approximately 6 weeks",{"measure":66,"description":67,"timeFrame":68},"Number of Participants Who Discontinue Study Treatment Due to an AE","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.","Up to approximately 4 weeks","ALL","18 Years","65 Years",true,{"inclusion":74,"exclusion":76,"raw_text":81},[75],"Has a body-mass index (BMI) between 18 and 35 kg\u002Fm\\^2",[77,78,79,80],"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 cancer (malignancy)","Has a history of significant multiple and\u002For severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or nonprescription drugs or food","Has a positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a body-mass index (BMI) between 18 and 35 kg\u002Fm\\^2\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\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 cancer (malignancy)\n* Has a history of significant multiple and\u002For severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or nonprescription drugs or food\n* Has a positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"Pinnacle Research Group ( Site 0002)","Anniston","Alabama","36207","United States",{"lat":93,"lon":94},33.65983,-85.83163,[],[97],{"name":98,"affiliation":99,"role":100},"Medical Director","Merck Sharpe & Dohme LLC","STUDY_DIRECTOR",[],[103],{"label":104,"url":105},"Merck Clinical Trials Information","http:\u002F\u002Fwww.merckclinicaltrials.com",{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Healthy Volunteers",[],{"nct_id":4,"found":72,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This interventional study plans to enroll 14 healthy participants. It will investigate the effect of MK-8527 on methadone levels.","completed","Study of MK-8527 and Methadone in Healthy Volunteers","This study is looking at how a medicine called MK-8527 affects levels of methadone in the body. Researchers want to understand what happens to methadone in healthy people after they take MK-8527. The study will measure the amount of methadone in your blood for up to 24 hours after taking the medicines. You might be able to join if you are a healthy adult between 18 and 65 years old with a body mass index (BMI) between 18 and 35. People with certain health conditions, like heart or kidney problems, cannot participate. The study aims to enroll 14 participants, but its current recruitment status is unclear.","The primary measurements will be taken for up to 24 hours after dosing.",106,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]