An Open-label, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUClast of YH25448
研究概览
简要总结
Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.
详细描述
This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.
It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed of the investigational nature of this study and voluntarily agree to participate in this study.
- •Subjects with BMI range of ≥18.5 kg/m2 and < 30.0 kg/m2 and weighing ≥ 50 kg
- •Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis
- •Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent
排除标准
- •Clinically significant chronic infection (e.g. AIDS) or clinically significant medical or psychiatric illness
- •Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg)
- •A marked baseline prolongation of QTc greater than 450 msec by Bazett's formula
- •Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
研究组 & 干预措施
Group 1
YH25448 240mg single dose in korean
干预措施: YH25448 240mg (Drug)
Group 2
YH25448 240mg single dose in caucasian
干预措施: YH25448 240mg (Drug)
结局指标
主要结局
AUClast of YH25448
时间窗: 0-192 hrs
Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448
Cmax of YH25448
时间窗: 0-192 hrs
Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448
次要结局
- AUCinf of YH25448(0-192 hrs)
- Tmax of YH25448(0-192 hrs)
- t1/2 of YH25448(0-192 hrs)
- CL/F of YH25448(0-192 hrs)
- Vd/F of YH25448(0-192 hrs)