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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Healthy subjects will be given TGRX-678 240 mg orally on day 1.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Urine radioactivity
\[C14\]TGRX-678 radioactivity detected in urine
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Fecal radioactivity
\[C14\]TGRX-678 radioactivity detected in feces
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Plasma AUC (Area under curve) percentage
percentage of \[C14\]TGRX-678 radioactivity in plasma
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Urine %Dose
percentage of \[C14\]TGRX-678 radioactivity in urine
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Fecal %Dose
percentage of \[C14\]TGRX-678 radioactivity in feces
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Plasma Cmax
Maximum concentration of \[C14\]TGRX-678 measured in plasma
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Plasma Tmax
Time to maximum concentration of \[C14\]TGRX-678 measured in plasma
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
Plasma AUC(0-t)
Area under curve for TGRX-678 plasma concentration from before dose to last measureable timepoint
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing
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Adverse events/serious adverse events
to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing or the day sample collection is completed