A Clinical Study to Evaluate the Effect of Renal Impairment on the Single-Dose Pharmacokinetics of MK-1084
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of calderasib
研究概览
简要总结
The goal of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of calderasib when it is given to people with RI and if people with RI can tolerate it.
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 main inclusion criteria include but are not limited to the following:
- •All participants:
- •- Has a BMI ≥18.0 and ≤40.0 kg/m^2
- •Participants with severe or moderate RI:
- •With the exception of RI, is sufficiently healthy for study participation
- •Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year
- •Participants with normal renal function:
- •- Is medically healthy
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •All participants:
- •Has a history of cancer (malignancy)
- •Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
- •Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
- •Participants with severe or moderate RI:
- •Has a history or presence of renal artery stenosis
- •Has a renal transplant or nephrectomy
研究组 & 干预措施
Panel A: Severe RI
Participants with severe RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.
干预措施: Calderasib (Drug)
Panel B: Moderate RI
Participants with moderate RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.
干预措施: Calderasib (Drug)
Panel C: Healthy
Healthy participants will be administered a single oral dose of calderasib on Day 1 under fasting conditions.
干预措施: Calderasib (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of calderasib
时间窗: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of calderasib
时间窗: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the AUC0-last of calderasib.
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of calderasib
时间窗: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of calderasib.
Plasma Concentration of calderasib at 24 Hours Postdose (C24)
时间窗: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the C24 of calderasib.
Maximum Plasma Concentration (Cmax) of calderasib
时间窗: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Cmax of calderasib.
Time to Maximum Plasma Concentration (Tmax) of calderasib
时间窗: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Tmax of calderasib.
Apparent Terminal Half-life (t1/2) of calderasib
时间窗: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
Apparent Clearance (CL/F) of calderasib
时间窗: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the CL/F of calderasib.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of calderasib
时间窗: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
次要结局
- Number of Participants Who Experience an Adverse Event(Up to approximately 2 weeks)
- Number of Participants Who Discontinue From the Study Due to an Adverse Event(Up to approximately 2 weeks)
- Total Amount of calderasib Excreted Unchanged in Urine (Ae)(At designated timepoints (up to approximately 1 day postdose))
- Total Amount of calderasib Excreted Unchanged in Urine From 0 to 24 Hours (Ae0-24)(At designated timepoints (up to 24 hours postdose))
- Fraction of calderasib Excreted Unchanged in Urine (fe)(At designated timepoints (up to approximately 1 day postdose))
- Renal Clearance (CLr) of calderasib(At designated timepoints (up to approximately 1 day postdose))