A Phase 1 Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]MK-1084 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma MK-1084
研究概览
简要总结
The purpose of this study is to learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •include but are not limited to the following:
- •Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization.
- •Has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at screening
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- •Has a history of cancer.
研究组 & 干预措施
Carbon-14 radiolabeled [14C] MK-1084
Participants receive single oral dose of calderasib on Day 1.
干预措施: [14C]Calderasib (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Bood samples will be collected to determine the AUC0-inf of MK-1084 in plasma.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-last of MK-1084 in plasma.
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-24 of plasma MK-1084 in plasma.
Maximum Concentration (Cmax) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Cmax of MK-1084 in plasma.
Concentration at 24 hours postdose (C24) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the C24 of MK-1084 in plasma.
Time to Reach Maximum Concentration (Tmax) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Tmax of MK-1084 in plasma.
Apparent Half Life (t½) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the t1/2 of MK-1084 in plasma.
Apparent Total Clearance (CL/F) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the CL/F of MK-1084 in plasma.
Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Vz/F of MK-1084 in plasma.
AUC0-inf/Total Radioactivity Ratio of plasma MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of MK-1084 in plasma.
Amount Excreted in the Urine (Aeu) of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the Aeu of MK-1084
Cumulative Aeu of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative Ae of MK-1084.
Percentage Excreted in the Urine (feu) of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the feu of MK-1084.
Cumulative feu of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative feu of MK-1084.
Amount Excreted in the Feces (Aef) of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the Aef of MK-1084.
Metabolites in Plasma of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the metabolites of MK-1084.
Cumulative Aef of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative Aef of MK-1084.
Percentage Excreted in the Feces (fef) of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the fef of MK-1084.
Cumulative fef of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative fef of MK-1084.
Metabolites in Urine of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the metabolites of MK-1084.
Metabolites in Feces of MK-1084
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the metabolites of MK-1084.
Time to Reach Maximum Concentration (Tmax) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Tmax of calderasib in plasma.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Bood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-24 of plasma calderasib in plasma.
Maximum Concentration (Cmax) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Concentration at 24 hours postdose (C24) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the C24 of calderasib in plasma.
Apparent Half Life (t½) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Apparent Total Clearance (CL/F) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
AUC0-inf/Total Radioactivity Ratio of plasma Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of calderasib in plasma.
Amount Excreted in the Urine (Aeu) of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the Aeu of calderasib
Cumulative Aeu of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative Ae of calderasib.
Percentage Excreted in the Urine (feu) of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the feu of calderasib.
Cumulative feu of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative feu of calderasib.
Amount Excreted in the Feces (Aef) of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the Aef of calderasib.
Cumulative Aef of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative Aef of calderasib.
Percentage Excreted in the Feces (fef) of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the fef of calderasib.
Cumulative fef of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative fef of calderasib.
Metabolites in Plasma of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the metabolites of calderasib.
Metabolites in Urine of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the metabolites of calderasib.
Metabolites in Feces of Calderasib
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the metabolites of calderasib.
次要结局
- Number of Participants Experiencing an Adverse Event (AE)(Up to ~ 28 days)
- Number of Participants Discontinuing Study Treatment due to an AE(Up to ~ 28 days)