An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.

Merck Sharp & Dohme LLC0 个研究点目标入组 22 人开始时间: 2027年1月22日最近更新: 2026年7月16日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Merck Sharp & Dohme LLC
入组人数: 22
主要终点: Area Under the Plasma Concentration-Time Curve from Dosing to Infinity (AUC0-∞) of Ulonivirine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Mild and Moderate HI (Panels A and B):
•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)
•Healthy Controls (Panel C):
•Is in good health
•All Participants (Panels A to C):
•Has a body mass index (BMI) ≥18.5 and ≤40 kg/m^2, inclusive
•If male, uses contraception in accordance with local regulations
•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/uses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical/menstrual/recent sexual history for review by the investigator

排除标准

•Mild and Moderate HI (Panels A and B):
•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
•Is not in sufficient health
•Is institutionalized/mentally or legally incapacitated
•Is positive for human immunodeficiency virus (HIV)-1 or HIV-2
•Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start
•Is taking medication for a chronic condition and has not been on a stable regimen for ≥ 1 month
•Healthy Controls (Panel C):
•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
•Is mentally or legally incapacitated
•Is positive for hepatitis B virus surface antigen (HBsAg), hepatitis C antibodies, HIV-1, or HIV-2
•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
•All Participants (Panel A to C):
•Has a history of cancer (malignancy)
•Has a history of significant multiple and/or severe allergies
•Has known hypersensitivity to the active substance or any of the excipients of the study drug
•Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to Screening

研究组 & 干预措施

Panel A: Mild HI

Experimental

Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1.

干预措施: Ulonivirine (Drug)

Panel B: Moderate HI

Experimental

Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1.

干预措施: Ulonivirine (Drug)

Panel C: Healthy Controls

Active Comparator

Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1.

干预措施: Ulonivirine (Drug)