[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446479":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":35,"locations":35,"responsibleParty":36,"collaborators":35,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":35,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":35,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":35,"overallStatus":58,"whyStopped":35,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":35},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Panel A: Mild HI","EXPERIMENTAL","Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1.",[13],"Drug: Ulonivirine",{"label":15,"type":10,"description":16,"interventionNames":17},"Panel B: Moderate HI","Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Panel C: Healthy Controls","ACTIVE_COMPARATOR","Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Ulonivirine","Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.",[9,15,19],[30],"MK-8507",[32],{"name":33,"affiliation":5,"role":34},"Medical Director","STUDY_DIRECTOR",null,{"type":37,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100446479","phase-1-ulonivirine-mk-8507-in-participants-with-mild-or-moderate-hepatic-impairment-mk-8507-014-100446479",false,"NCT05093972","Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)","An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.","Inclusion Criteria:\n\nMild and Moderate HI (Panels A and B):\n\n* Has a diagnosis of chronic (\\>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function)\n\nHealthy Controls (Panel C):\n\n* Is in good health\n\nAll Participants (Panels A to C):\n\n* Has a body mass index (BMI) ≥18.5 and ≤40 kg\u002Fm\\^2, inclusive\n* If male, uses contraception in accordance with local regulations\n* If female, is not pregnant or breastfeeding and one of the following applies: 1) is not a woman of childbearing potential (WOCBP), or 2) is a WOCBP and is abstinent\u002Fuses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical\u002Fmenstrual\u002Frecent sexual history for review by the investigator\n\nExclusion Criteria:\n\nMild and Moderate HI (Panels A and B):\n\n* Has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study\n* Is not in sufficient health\n* Is institutionalized\u002Fmentally or legally incapacitated\n* Is positive for human immunodeficiency virus (HIV)-1 or HIV-2\n* Has received antiviral and\u002For immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start\n* Is taking medication for a chronic condition and has not been on a stable regimen for ≥ 1 month\n\nHealthy Controls (Panel C):\n\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Is mentally or legally incapacitated\n* Is positive for hepatitis B virus surface antigen (HBsAg), hepatitis C antibodies, HIV-1, or HIV-2\n* Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to first dose of study drug\n\nAll Participants (Panel A to C):\n\n* Has a history of cancer (malignancy)\n* Has a history of significant multiple and\u002For severe allergies\n* Has known hypersensitivity to the active substance or any of the excipients of the study drug\n* Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to Screening",true,"ALL","18 Years","75 Years",{"count":50,"type":51},22,"ESTIMATED","INTERVENTIONAL",[54],"PHASE1","The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.",[57],"Hepatic Insufficiency","NOT_YET_RECRUITING","2025-02-14",{"date":61,"type":62},"2025-02-18","ACTUAL",{"date":64,"type":51},"2026-04-07",{"date":66,"type":51},"2026-09-10",{"name":5,"class":6}]