tgrx-326 pharmacokinetic mass balance

Conditions: Non Small Cell Lung Cancer

Summary: this is a pharmacokinetic study for tgrx-326 on mass balance to evaluate distribution, metabolism and excretion of tgrx-326, an alk inhibitor indicated for treatment of non-small cell lung cancer.

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-326 using the carbon-14 labelled isotope of tgrx-326 compound. safety evaluation will also be conducted.

Eligibility criteria:
inclusion criteria: * healthy adult males * age between 18 and 45 years old (both limits included) * body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg * willing to consent * able to communicate with investigator and complete study according to study protocol exclusion criteria: * clinically significant results from comprehensive physical and clinical examinations * positive results on hepatitis, hiv or syphilis * clinically significant results from eye examination * usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening * usage of any prescription or non-prescription drug, chinese herbal medicine or dietary supplements * presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement * presence of any condition that could affect drug absorption * reception of major surgery within 6 months before screening, or surgical wounds not completely healed * presence of allergic reactions or may be allergic to ingredients in the investigational drug * presence of hemorrhoids, or having history of or is having conditions that cause bloody feces * habitual congestion or diarrhea * alcohol abuse or excessive alcohol consumption within 6 months before screening * excessive smoking within 3 months before screening * substance abuse or positive results on urine substance test * habits of grapefruit juice consumption or excessive caffeinated drinks consumption * history of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies * 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, 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