An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Maximum Plasma Concentration (Cmax) of NHC
研究概览
简要总结
This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. This study will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and the urinary excretion of NHC after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. The primary hypothesis is that the plasma PK participants with severe renal impairment will be similar to that observed in the healthy mean matched 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
- •The key Inclusion Criteria include but are not limited to the following:
- •Body mass index (BMI) ≥18.5 kg/m^2 and ≤35 kg/m^2
- •Healthy participants: Baseline estimated glomerular filtration rate (eGFR) ≥90 mL/min based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation
- •Severe renal impairment participants: Baseline estimated glomerular filtration rate (eGFR) <30 mL/min based on the 2021 CKD-EPI Creatinine equation
排除标准
- •The key Exclusion Criteria include but are not limited to the following:
- •Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
- •History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
- •Severe renal impairment participants:
- •History or presence of renal artery stenosis
- •Had a renal transplant
- •Currently taking medications to treat chronic medical conditions associated with renal disease if participant has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of medication(s) within 4 hours prior to and 8 hours after administration of the study drug
研究组 & 干预措施
Panel A - Severe Renal Impairment Group
Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir.
干预措施: Molnupiravir (Drug)
Panel B - Healthy Control Group
Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir.
干预措施: Molnupiravir (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of NHC
时间窗: Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
Blood for plasma samples was collected at pre-specified time points to determine the Cmax of NHC.
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)
时间窗: Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC.
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: Up to Day 15
An AE was 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. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
次要结局
- Fraction of the Dose Administered Excreted in Urine (Fe) of NHC(Predose, 4, 8, 12 and 24 hours postdose)
- Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC)(Predose, 4, 8, 12 and 24 hours postdose)
- Renal Clearance (CLr) of NHC(Predose, 4, 8, 12 and 24 hours postdose)