[14C]TGRX-678 Mass Balance Study in Chinese Healthy Male Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Urine radioactivity
研究概览
简要总结
This is a pharmacokinetic study for [14C]TGRX-678 on mass balance to evaluate distribution, metabolism and excretion of TGRX-678, a tyrosine kinase inhibitor indicated for treatment of chronic myeloid leukemia.
详细描述
This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-678 using the Carbon-14 labelled isotope of TGRX-678 compound. Safety and pharmacokinetic evaluation will also be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males
- •age between 18 and 45 (both included) years old
- •body weight index between 19.0 and 26.0 kg/m2 (both included, and body weight not lower than 50 kg
- •can volunteeringly consent
- •can communicate well with investigators and complete study according to protocol requirements
排除标准
- •abnormal and of clinical significance results on physical exam, regular laboratory tests, thyroid function, anal check, chest x-ray, abdominal ultrasound check or 12-lead ECG
- •positive test results on hepatitis B surface antigen/ E antigen, hepatitis C antibody, HIV antigen/antibody or syphylus antibody
- •abnornal and of clinical significance results on eye exam
- •usage of any inducers or inhibitors for drug metabolism enzymes (especially CYP3A4) within 30 days of screening
- •usage of any prescriptional drug, OTC drug, herbal medicine, traditional Chinese medicine, or food supplements (i.e., vitamins, calcium) within 14 days of screening
- •history of any clinically significant serious diseases or any conditions that at investigator's discretion may affect study results
- •have condition that may affect drug absoption
- •received major surgery or with un-healed surgical wounds within 6 months of screening
- •have allergies to at least 2 substances or at investigator's discretion may be allergic to investigational drug or any excipients
- •have hemorrhoids; have history of or is having conditions that cause bloody feces, irritable bowel syndrome, or inflammatory bowel disease
- •habitutory constipation or diarrhea
- •alcohol abuse, or frequent use of alcohol within 6 months of screening
- •smoking of more than 5 cigarettes per day within 3 months of screening, or habitutory use of nicotine products and cannot quit during study
- •drug abuse, or use of soft drug (marajuana) within 3 months of screening, or use of hard drug (phenylamine or PCP type drugs) within 1 year of screening, or tested positive in urine drug test during screening
- •habitutory use of grape fruit juice, or overuse of tea, coffee or caffeinated drugs, and cannot quit during study
- •long-term occupational exposure to radioactive conditions, or have history of significant radioactive substance exposure or participated in clinical study using radioactive-labeled drugs within 1 year of current study
- •Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
- •Participation in any other clinical studies within 3 months before screening
- •Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study
- •Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion
- •Blood donation or blood loss of > 400 ml within 3 months before screening; blood donation or blood loss of > 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening; received blood donation within 1 months of study, or planning to donate blood within 3 months after study completion
- •Having special dietary requirements and unable to follow the uniform dietary plan in the study
- •Any conditions that the investigator deemed unfit for the study
研究组 & 干预措施
TGRX-678
healthy male subjects will be given 240mg/250uCi[14C]TGRX-678 in suspension
干预措施: [14C]TGRX-678 (Drug)
结局指标
主要结局
Urine radioactivity
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
\[C14\]TGRX-678 radioactivity detected in urine
Fecal radioactivity
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
\[C14\]TGRX-678 radioactivity detected in feces
Plasma AUC (Area under curve) percentage
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
percentage of \[C14\]TGRX-678 radioactivity in plasma
Urine %Dose
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
percentage of \[C14\]TGRX-678 radioactivity in urine
Fecal %Dose
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
percentage of \[C14\]TGRX-678 radioactivity in feces
Plasma Cmax
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Maximum concentration of \[C14\]TGRX-678 measured in plasma
Plasma Tmax
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Time to maximum concentration of \[C14\]TGRX-678 measured in plasma
Plasma AUC(0-t)
时间窗: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Area under curve for TGRX-678 plasma concentration from before dose to last measureable timepoint
次要结局
- Adverse events/serious adverse events(Day-1 (day before dosing), Day 1 to Day 54 after dosing or the day sample collection is completed)