NCT07734610尚未招募1 期
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Severe Renal Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
研究概览
简要总结
The purpose of this study is to learn what happens to nemtabrutinib in a person's body when given to participants with severe kidney disease and to healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 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 body mass index (BMI) ≥18.0 and ≤40.0 kg/m^2
- •Participants with Severe Renal impairment (RI):
- •The participant has stable renal function as determined by historical measurements.
- •Healthy volunteers:
- •Is medically healthy with no clinically significant medical history
排除标准
- •The main exclusion criteria 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
Nemtabrutinib
Experimental
All participants will receive a single oral dose of nemtabrutinib on Day 1.
干预措施: Nemtabrutinib (Drug)
结局指标
主要结局
Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
时间窗: At designated timepoints up to approximately 336 hours postdose
Blood samples will be collected to determine the AUC0-inf of Nemtabrutinib in plasma.
次要结局
- Area Under the Concentration Versus Time Curve from 0 to 24 Hours Postdose (AUC0-24) of Nemtabrutinib(Up to approximately 24 hours postdose)
- Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Nemtabrutinib(At designated timepoints up to approximately 336 hours postdose)
- Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma(At designated timepoints up to approximately 336 hours postdose)
- Concentration at 24 Hours Postdose (C24) of Nemtabrutinib in Plasma(Up to approximately 24 hours postdose)
- Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib in Plasma(At designated timepoints up to approximately 336 hours postdose)
- Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma(At designated timepoints up to approximately 336 hours postdose)
- Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib(At designated timepoints up to approximately 336 hours postdose)
- Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Nemtabrutinib in Plasma(At designated timepoints up to approximately 336 hours postdose)
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 15 days)
- Number of Participants Who Discontinue From the Study Due to an AE(Up to approximately 15 days)
研究者
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