A Randomized, Open-label, Single-dose, 3-cycle, 6-sequence, Crossover Study Evaluating Food Effect on Pharmacokinetic Profiles of TGRX-326 in Chinese Healthy Subjects and Effect of Drug Specification on Bioavailability in Human
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma AUC(0-inf)
研究概览
简要总结
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment
详细描述
This study is designed as single-center, randomized, open-label, 3-cycle, 6-sequence and crossover design to evaluate 1) food effect on PK profile of TGRX-326; 2) effect of different specifications of TGRX-326 on human bioavailability. Safety for food effect on TGRX-326 and safety for different TGRX-326 specifications were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a PK assessment study, hence only bio-sample analysis personnel were masked for the type of treatment received for each sample to avoid bias in analysis. Other study personnel, including participants, investigators and staffs were not masked for treatment types.
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
- •able to understand the purpose, methods and possible adverse events of the study and agree to volunteering consent before the start of study
- •healthy subject; male or female
- •Age between 18 and 55 (inclusive)
- •body mass index (BMI) between 19.0 and 26.0 (inclusive), male weight <=50 kg, female weight <=45 kg
- •normal/ clinically insignificant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.)
- •participant/partner of the participant does not have plans for child bearing from screening until 6 months after study, and is willing to take contraceptive measures during study period and for 6 months, and does not have plans to donate sperm/egg during the said period
排除标准
- •history of allergic reactions, or allergic to any components to the study drugs that by investigator's judgement unsuitable for the study
- •any clinically significant conditions that could affect study outcomes, safety or compliance
- •history of major surgery within 3 months before first dose, or have plans to receive surgery during the study, or history of any surgery that could affect drug absorption, distribution, metabolism and excretion
- •have difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
- •history of substance abuse
- •have special food requirement or cannot follow food requirement of the study, or lactose intolerant
- •use of any investigational drug or participation of any clinical study (for drug or medical device) within 3 months before first dose, or cannot participate the study in person/on site
- •history of blood donation, blood loss (>= 400 mL, excluding normal blood loss during female menstrual period), or reception of blood transfusion within 3 months before screening
- •history of daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study
- •history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or cannot avoid alcohol consumption during study
- •history of large tea/coffee/caffeinated drink intake (more than 8 cups per day) within 3 months before first dose
- •history of irregular dietary schedule within 1 months of first dose (including, dieting, overeating, low sodium intake, etc.)
- •use of any prescription / over-the-counter drug, or Chinese herbal medication, or health supplementary products within 14 days of test article administration
- •vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period
- •any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody
- •alcohol breathing test results of > 0.0 mg/100mL for blood alcohol concentration
- •positive test results on substance use (including, morphine, methylamphetamine, ketamine, tetrahydrocannabinol, methylene-dioxy-methyl-amphetamine)
- •female in pregnancy or breastfeeding period, or positive pregnancy test result
- •history of unprotected sexual activities within 14 days before first dose
- •consumption of food or drink rich in caffeine/xanthine (such as chocolate, coffee, tea, coke) or food/food product of grapefruit, dragon fruit, mango, tangerine, or any food that could affect drug absorption, distribution, metabolism and excretion
- •any reasons that is deemed unsuitable for study participation as determined by investigator
结局指标
主要结局
Plasma AUC(0-inf)
时间窗: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma
Plasma AUC(0-t)
时间窗: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-326 as measured in plasma
Plasma Cmax
时间窗: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Maximum concentration of TGRX-326 measured in plasma
次要结局
- Plasma Tmax(During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles))
- Plasma clearance (CL/F)(During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles))
- AUC(%Extrap)(During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles))
- Plasma volume of distribution (Vz/F)(During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles))
- terminal elimination rate constant (lambda-z)(During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles))
- Elimination half-life (T1/2-Z)(During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles))
- Adverse events/serious adverse events(through completion of the study, a total duration of 37 days)