tgrx-678 pharmacokinetic mass balance

Conditions: Chronic Myeloid Leukemia

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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