An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy matched controls.
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
- •Has a BMI ≥18.5 and ≤35 kg/m2
- •Diagnosis of chronic (>6 months) stable Hepatic Impairment (HI) with features of cirrhosis due to any etiology (Moderate HI arm only)
- •Has a score on the Child-Pugh scale ranging from 7 to 9 (Moderate HI arm only)
- •In good health (except for Moderate HI)
排除标准
- •Anticipated survival of <3 months (Moderate HI arm only)
- •Received antiviral and/or immune modulating therapy (Moderate HI only) for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) within 90 days prior to study start
- •History of clinically significant abnormalities or diseases (Healthy matched arm only).
- •History of cancer
- •Major surgery and/or donated or lost 1 unit of blood
- •Taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month (Moderate HI arm only) and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.
研究组 & 干预措施
Moderate Hepatic Impairment
Participants with moderate hepatic impairment received a single oral dose of molnupiravir 800 mg on Day 1.
干预措施: Molnupiravir (Drug)
Healthy-Matched Control Group
Healthy matched participants received a single oral dose of molnupiravir 800 mg on Day 1.
干预措施: Molnupiravir (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC)
时间窗: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
The plasma AUC0-∞ of NHC is reported.
Maximum Plasma Concentration (Cmax) of NHC
时间窗: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
The plasma Cmax of NHC is reported.
次要结局
- Number of Participants Experiencing ≥1 Adverse Event (AE)(Up to ~ 14 days)