A Two-Part Study to Evaluate the Effects of Multiple Doses of Itraconazole and Multiple Doses of Phenytoin on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of Calderasib
研究概览
简要总结
The goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 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 kg/m^2 and ≤32 kg/m^2
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History of cancer (malignancy)
- •Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- •Part 1 Only:
- •- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)
- •Pat 2 Only:
- •- History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions
研究组 & 干预措施
Part 1: Calderasib + Itraconazole
Part 1: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive itraconazole once daily (QD) for 7 consecutive days (Day 1 - Day 7), plus a single dose of calderasib administered approximately 2 hours after itraconazole dosing on Day 5. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.
干预措施: Calderasib (Drug)
Part 1: Calderasib + Itraconazole
Part 1: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive itraconazole once daily (QD) for 7 consecutive days (Day 1 - Day 7), plus a single dose of calderasib administered approximately 2 hours after itraconazole dosing on Day 5. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.
干预措施: Itraconazole (Drug)
Part 2: Calderasib + Phenytoin
Part 2: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive phenytoin three times daily (TID) for 14 consecutive days (Day 1 - Day 14), plus a single dose of calderasib co-administered on the morning of Day 13. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.
干预措施: Calderasib (Drug)
Part 2: Calderasib + Phenytoin
Part 2: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive phenytoin three times daily (TID) for 14 consecutive days (Day 1 - Day 14), plus a single dose of calderasib co-administered on the morning of Day 13. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.
干预措施: Phenytoin (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of Calderasib
时间窗: Pre-dose and at designated time points up to 72 hours post dose
Blood samples will be collected to determine the AUC0-Inf of calderasib.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 41 days)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 25 days)
- Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of Calderasib(Pre-dose and at designated time points up to 72 hours post dose)
- Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib(Pre-dose and at designated time points up to 24 hours post dose)
- Maximum Plasma Concentration (Cmax) of Calderasib(Pre-dose and at designated time points up to 72 hours post dose)
- Plasma Concentration at 24 Hours (C24) of Calderasib(Pre-dose and at designated time points up to 24 hours post dose)
- Time to Maximum Plasma Concentration (Tmax) of Calderasib(Pre-dose and at designated time points up to 72 hours post dose)
- Apparent Terminal Half-life (t1/2) of Calderasib(Pre-dose and at designated time points up to 72 hours post dose)
- Apparent Clearance (CL/F) of Calderasib(Pre-dose and at designated time points up to 72 hours post dose)
- Apparent volume of distribution during terminal phase (Vz/F) of Calderasib(Pre-dose and at designated time points up to 72 hours post dose)