TGRX-326 Pharmacokinetic Mass Balance

Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants

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.

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