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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Healthy subjects will be given TGRX-326 60 mg orally on day 1.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Urine radioactivity
\[C14\]TGRX-326 radioactivity detected in urine
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Fecal radioactivity
\[C14\]TGRX-326 radioactivity detected in feces
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma AUC (Area under curve) percentage
percentage of \[C14\]TGRX-326 radioactivity in plasma
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Urine %Dose
percentage of \[C14\]TGRX-326 radioactivity in urine
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Fecal %Dose
percentage of \[C14\]TGRX-326 radioactivity in feces
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma Cmax
Maximum concentration of \[C14\]TGRX-326 measured in plasma
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma Tmax
Time to maximum concentration of \[C14\]TGRX-326 measured in plasma
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Adverse events/serious adverse events
to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From screening through completion of study, an average of 1 to 1.5 months.