NCT05454098已完成1 期
A Food Effect Phase I Study of the Clifutinib in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (male or female), age greater than or equal to 18 years and less than or equal to 45 years;
- •Weight ≥50 kg (≥45 kg for female), and have a body mass index (BMI) between 18 and 28 (including 18 and 28) at screening;
- •Physical examination, clinical laboratory examination and other related examinations are normal or acceptable deviations that are judged to be not clinically significant by the investigator;
- •Male or female subjects with child-bearing potential must agree to use effective contraception during the study and within 6 months after the administration of the last dose, and sperm donation is not allowed for male subjects during the study; female subjects must be non-pregnant and non-lactating；
- •Volunteer to participate in this study, understand the study procedures and sign the informed consent prior to any study specific procedures, good compliance and willing to follow study procedures.
排除标准
- •Have a history of or current cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
- •Unable to tolerate standard meals;
- •Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 ms (female >480 ms), or history of long QT syndrome；
- •Have received live vaccine(s) within 3 months prior to screening;
- •Have used over-the-counter or prescription medication , including herbal medications, within 14 days prior to dosing and during the study;
- •Have known allergy to any drug or food;
- •Smoking more than 5 cigarettes per day (or equivalent in tobacco or nicotine products) within 3 months prior to screening, or unwilling to abide by smoking restrictions during the study;
- •Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody ,human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody;
- •Known history of drug abuse
研究组 & 干预措施
Fed states in healthy subjects
Experimental
A single 40mg dose of Clifutinib administered in a fed state.
干预措施: Clifutinib with fed state (Drug)
Fasted states in healthy subjects
Experimental
A single 40mg dose of Clifutinib administered in a Fasted state.
干预措施: Clifutinib with fasted state (Drug)
结局指标
主要结局
Cmax
时间窗: 4 weeks
Pharmacokinetics parameters in fasting state and fed state
AUC0-∞
时间窗: 4 weeks
Pharmacokinetics parameters in fasting state and fed state
次要结局
- Adverse Events(Through study completion, an average of 4 weeks)
研究者
研究点 (1)
Loading locations...
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