An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of MK-1084 on the Single-Dose Pharmacokinetics of Rosuvastatin and Metformin in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Rosuvastatin
研究概览
简要总结
Researchers want to learn about calderasib when given with rosuvastatin and metformin in healthy people. The goal of this study is to compare the amount of rosuvastatin and metformin in a person's body over time when given with and without calderasib
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（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:
- •- Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has history of cancer (malignancy)
- •Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
研究组 & 干预措施
Rosuvastatin + metformin
Participants will receive rosuvastatin plus metformin
干预措施: Metformin (Drug)
Rosuvastatin + metformin
Participants will receive rosuvastatin plus metformin
干预措施: Rosuvastatin (Drug)
Rosuvastatin + metformin + Calderasib
Participants will receive rosuvastatin plus metformin plus calderasib
干预措施: Metformin (Drug)
Rosuvastatin + metformin + Calderasib
Participants will receive rosuvastatin plus metformin plus calderasib
干预措施: Calderasib (Drug)
Rosuvastatin + metformin + Calderasib
Participants will receive rosuvastatin plus metformin plus calderasib
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Rosuvastatin
时间窗: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin
Maximum Plasma Concentration (Cmax) of Rosuvastatin
时间窗: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin
AUC0-inf of Metformin
时间窗: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin
次要结局
- AUC0-24hrs of Calderasib(Day 1: Predose and at designated timepoints up to 24 hours post-dose)
- Plasma Concentration at 24 Hours (C24) of Calderasib(24 hours post-dose)
- Cmax of Calderasib(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Vz/F of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Rosuvastatin(Day 1: Predose and at designated timepoints up to 120 hours post-dose)
- Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Rosuvastatin(Day 1: Predose and at designated timepoints up to 24 hours post-dose)
- AUC0-last of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin(Day 1: Predose and at designated timepoints up to 120 hours post-dose)
- Apparent Clearance (CL/F) of Rosuvastatin(Day 1: Predose and at designated timepoints up to 120 hours post-dose)
- Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin(Day 1: Predose and at designated timepoints up to 120 hours post-dose)
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of Rosuvastatin(Day 1: Predose and at designated timepoints up to 120 hours post-dose)
- AUC0-24hrs of Metformin(Day 1: Predose and at designated timepoints up to 24 hours post-dose)
- Cmax of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Tmax of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- t1/2 of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- CL/F of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Amount of Metformin Excreted Unchanged in Urine (Ae)(Day 1: Predose and at designated timepoints up to 48 hours post-dose)
- Fraction of Metformin Excreted Unchanged in Urine (Fe)(Day 1: Predose and at designated timepoints up to 48 hours post-dose)
- Renal Clearance of Metformin (CLr)(Day 1: Predose and at designated timepoints up to 48 hours post-dose)
- Number of Participants Who Experience an Adverse Avent (AE)(Up to approximately 28 days after first dose)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 14 days after first dose)
- t1/2 of Calderasib(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Tmax of Calderasib(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- CL/F of Calderasib(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Vz/F of Calderasib(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- AUC0-inf of Calderasib(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- AUC0-last of Calderasib(Day 1: Predose and at designated timepoints up to 72 hours post-dose)