Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Plasma Tmax
研究概览
简要总结
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678
详细描述
This study is designed as single-center, single-dose, randomized, open-label and parallel-comparison to evaluate food effect on PK profile of TGRX-678 in healthy subjects. Safety and tolerability of the drug is also evaluated during study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 participants, male or female
- •Age between 18 and 45 (both inclusive)
- •Body Weight: male ≥ 50 kg, female ≥ 45 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m^2 (both inclusive)
- •Signing informed concent at own will
- •Able to communicate with researcher and able to complete study per protocol instruction
排除标准
- •Clinically significant abnormal results in lab test, physical exam or 12-lead electrocardiogram (ECG) test
- •Positive results for Hepatitis B, Hepatitis C, HIV or Syphilis
- •QT interval elongation as indicated by 12-lead ECG test during screening period
- •Use of any medication that could impact CYP3A4 enzyme activities within 30 days prior to Screening period
- •Use of any medication within 14 days of first dose of the investigational drug
- •Vaccinated within 30 days of first dose of the investigational drug, or planning to be vaccinated during study
- •History of instrumental cardiovascular diseases
- •Received major surgery within 6 months prior to Screening, or with surgical wounds not completely healed
- •History of any severe disease or conditions that could affect study results per investigator's discretion
- •History of allergic conditions or is allergic to components of the investigational drug
- •Having conditions that could affect drug absorption or difficulties to swallow
- •History of smoking of >5 cigarettes per day within 3 months prior to screening, or cannot stop tabacco using during study
- •History of alcohol abuse, or alcohol consumption of >14 unit alcohol within 3 months prior to screening
- •History of substance use, or tested positive for drug test during screening
- •History of specific food (i.e., grapefruit, mango) consumption, or/and large tea/coffee/caffeinated drink/grapefruit product intake of > 8 cups per day, within 2 weeks prior to first dose
- •Having special dietary requirement and cannot comply with food requirement of the study
- •Pregnant or breastfeeding female, or tested positive in pregnancy test
- •History of unprotected sexual activities within 1 month prior to screening
- •Having plans for pregnancy during the study and within 6 months after study completion; or not agreeing to take strict contraceptive measures during study and within 6 months after study completion
- •History of blood loss/ blood donation of ≥ 400 mL within 3 months prior to screening, or planning to donate blood within 1 month after study completion
- •Any reasons that is deemed unsuitable for study participation as determined by investigator
研究组 & 干预措施
High-fat Diet
Participants take TGRX-678 after high-fat meal intake
干预措施: TGRX-678 (Drug)
Fasting
Participants take TGRX-678 under fasting state
干预措施: TGRX-678 (Drug)
Low-fat Diet
Participants take TGRX-678 after low-fat meal intake
干预措施: TGRX-678 (Drug)
结局指标
主要结局
Plasma Tmax
时间窗: During Treatment period (Day 1 to Day 43)
Time to maximum concentration (Tmax) of TGRX-678 measured in plasma
Plasma Tlag
时间窗: During Treatment period (Day 1 to Day 43)
Time between drug administration to drug absorption (Tlag) as indicated by TGRX-678 plasma concentration
Plasma Cmax
时间窗: During Treatment period (Day 1 to Day 43)
Maximum concentration (Cmax) of TGRX-678 measured in plasma
Plasma AUC(0-t)
时间窗: During Treatment period (Day 1 to Day 43)
Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-678 as measured in plasma
Plasma AUC(0-inf)
时间窗: During Treatment period (Day 1 to Day 43)
Area Under drug concentration-time curve from time 0 to infinity for TGRX-678 as measured in plasma
AUC(%Extrap)
时间窗: During Treatment period (Day 1 to Day 43)
Calculated percentage of Area under curve for AUC(0-inf) that is from last measurable timepoint ot infinity, calculated based on TGRX-678 plasma concentration over time curve.
Half Life (T1/2)
时间窗: During Treatment period (Day 1 to Day 43)
Time for TGRX-678 to decrease from maximum plasma concentration to half of maximum plasma concentration
Plasma volume of distribution (Vz/F)
时间窗: During Treatment period (Day 1 to Day 43)
Apparent volume of distribution of TGRX-678 in plasma
Plasma clearance (CL/F)
时间窗: During Treatment period (Day 1 to Day 43)
Apparent clearance of TGRX-678 in plasma
次要结局
- Adverse Events (AE)(Starting from consent signing and until end of Treatment period (Day 1 to Day 43))