A Phase 1 Clinical Study to Evaluate the Absorption, Metabolism and Excretion of [14C]MK-8189 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8189
研究概览
简要总结
The purpose of this study is to learn what happens to elpipodect in a healthy person's body over time.
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, VS measurements, and ECGs performed before randomization.
- •Has a BMI ≥19 and ≤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] Elpipodect
Participants receive a dose of 4.5-mg immediate release (IR) (~ 50 μCi) orally on Day 1.
干预措施: [14C]Elpipodect (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8189
时间窗: Predose and postdose up to 24 hours
Blood samples will be collected to determine the AUC0-24 of MK-8189.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUClast of MK-8189.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-inf of MK-8189.
Maximum Concentration (Cmax) of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Cmax of MK-8189.
Time to Reach Maximum Concentration (Tmax) of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Tmax of MK-8189.
Apparent Half Life (t½) of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the t1/2 of MK-8189.
Amount Excreted (Ae) in Urine of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the Ae of MK-8189
%Dose Excreted in Urine of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the %dose of MK-8189
Amount Excreted (Ae) in Feces of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the Ae of MK-8189.
%Dose Excreted in Feces of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the %dose of MK-8189.
Metabolites in Plasma of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the metabolites of MK-8189.
Metabolites in Urine of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the metabolites of MK-8189.
Metabolites in Feces of MK-8189
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the metabolites of MK-8189.
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Elpipodect
时间窗: Predose and postdose up to 24 hours
Blood samples will be collected to determine the AUC0-24 of elpipodect.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUClast of elpipodect.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-inf of elpipodect.
Maximum Concentration (Cmax) of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Cmax of elpipodect.
Apparent Half Life (t½) of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the t1/2 of elpipodect.
Time to Reach Maximum Concentration (Tmax) of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Tmax of elpipodect.
Amount Excreted (Ae) in Urine of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the Ae of elpipodect
%Dose Excreted in Urine of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the %dose of elpipodect
Amount Excreted (Ae) in Feces of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the Ae of elpipodect.
%Dose Excreted in Feces of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the %dose of elpipodect.
Metabolites in Plasma of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the metabolites of elpipodect.
Metabolites in Urine of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the metabolites of elpipodect.
Metabolites in Feces of Elpipodect
时间窗: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the metabolites of elpipodect.
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)