An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-2828 in Participants With Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma
研究概览
简要总结
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.
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
- 24 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor.
- •Severe Renal Impairment Participants:
- •Has an estimated glomerular filtration rate (eGFR) < 30 mL/min), but is not on hemodialysis (HD)
- •ESRD on HD Participants:
- •Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for > 3 months prior to study entry
排除标准
- •include but are not limited to the following:
- •Renal Impairment Participants:
- •History of any illness, other than renal impairment, 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.
- •Healthy Matched Control Participants:
- •History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
研究组 & 干预措施
End Stage Renal Disease (ESRD) on Hemodialysis (HD)
Participants with ESRD will receive a single dose of MK-2828 on Day 1 in each of 2 periods, with a washout of at least 14 days between doses.
干预措施: MK-2828 (Drug)
Healthy Mean Matched Control
Participants with normal renal function will receive a single dose of MK-2828 on Day 1
干预措施: MK-2828 (Drug)
Severe Renal Impairment
Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1
干预措施: MK-2828 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma
时间窗: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the AUC0-inf of MK-2828
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-2828 in Plasma
时间窗: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the AUC0-last of MK-2828
Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of MK-2828 in Plasma
时间窗: Pre dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the AUC0-24 of MK-2828
Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma
时间窗: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the Cmax of MK-2828
Time of the Maximum Observed Concentration (Tmax) of MK-2828 in Plasma
时间窗: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the Tmax of MK-2828
Concentration at 24 Hours Postdose (C24) of MK-2828 in Plasma
时间窗: At designated time points up to 24 hours post dose
Blood samples will be collected to determine the C24 of MK-2828
Apparent Terminal Elimination Half-life (t1/2) of MK-2828 in Plasma
时间窗: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the t1/2 of MK-2828
Apparent Total Plasma Clearance (CL/F) of MK-2828
时间窗: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the CL/F of MK-2828
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of MK-2828 in Plasma
时间窗: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the Vz/F of MK-2828
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 14 days)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 2 days)
- Area Under the Concentration-time Curve From Start to End of Dialysis (AUCD) of MK-2828(Prior to hemodialysis (HD) and at designated time points until day 6)
- Area Under the Concentration-time Curve Determined from the Pre-dialyzer Line (AUCCa) of MK-2828(Prior to hemodialysis (HD) and at designated time points until day 6)
- Area Under the Concentration-time Curve Determined from the Post-dialyzer Line (AUCCv) of MK-2828(Prior to hemodialysis (HD) and at designated time points until day 6)
- Dialysis Clearance (CLD) of MK-2828 Based on Plasma(Prior to hemodialysis (HD) and at designated time points until day 6)
- Hemodialysis Extraction Ratio (ER_D) of MK-2828(Prior to hemodialysis (HD) and at designated time points until day 6)