A Phase 1, Open-Label, Two-Period Fixed Sequence Study to Evaluate the Effects of a Single Oral Dose of Ulonivirine (MK-8507) on the Single-Dose Pharmacokinetics of Atorvastatin and Metformin in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Atorvastatin
研究概览
简要总结
Researchers want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of atorvastatin and metformin in a person's body over time when given with and without ulonivirine.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Has body mass index (BMI) 18.0 and ≤ 32.0 kg/m^2
- •Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiogram (ECG)
排除标准
- •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
Atorvastatin + metformin + ulonivirine
In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine.
干预措施: Metformin (Drug)
Atorvastatin + metformin + ulonivirine
In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine.
干预措施: Atorvastatin (Drug)
Atorvastatin + metformin + ulonivirine
In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine.
干预措施: Ulonivirine (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Atorvastatin
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 atorvastatin
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
- Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Maximum Plasma Concentration (Cmax) of Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Plasma Concentration at 24 Hours (C24) of Atorvastatin(24 hours post-dose)
- Time to Maximum Plasma Concentration (Tmax) of Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Apparent Terminal Half-life (t1/2) of Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- AUC0-last of Atorvastatin Metabolite (2-OH Atorvastatin)(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- AUC0-inf of 2-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Cmax of 2-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- C24 of 2-OH Atorvastatin(24 hours post-dose)
- Tmax of 2-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- t1/2 of 2-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- AUC0-last of Atorvastatin Metabolite (4-OH Atorvastatin)(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- AUC0-inf of 4-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Cmax of 4-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- C24 of 4-OH Atorvastatin(24 hours post-dose)
- Tmax of 4-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- t1/2 of 4-OH Atorvastatin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- AUC0-last of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- Cmax of Metformin(Day 1: Predose and at designated timepoints up to 72 hours post-dose)
- C24 of Metformin(24 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)
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to approximately 21 days after first dose)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 7 days after first dose)