This is a single-center, non-randomized, open-label, single-cohort, single-dose phase I clinical study in healthy Chinese adult male subjects.
The main objectives of this study were as follows: 1. To quantitatively analyze the total radioactivity in excreta of healthy subjects after a single oral administration of \[14C\]SIM0270, and to obtain the data of human radioactive excretion rate and main excretion routes. 2. After a single oral administration of \[14C\]SIM0270 in healthy subjects, radioactive metabolite profiles in plasma, urine and feces were investigated to identify metabolites, and the metabolic pathway, main metabolites and elimination pathway of SIM0270 in human body were determined. 3. The total radioactivity in whole blood and plasma of healthy subjects after a single oral administration of \[14C\]SIM0270 was quantitatively analyzed, the pharmacokinetic characteristics of total radioactivity in plasma were evaluated, and the distribution of total radioactivity in whole blood and plasma was investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Use according to the prescribed protocol
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]SIM0270 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Following a single oral dose of 60 milligrams/150μCi of \[14C\]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.
Time frame: From Day 1 to Day 44
Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]SIM0270 Recovered in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Following a single oral dose of 60 milligrams/150μCi of \[14C\]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.
Time frame: From Day 1 to Day 44
Maximum 0bserved Concentration (Cmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Time frame: From 0 to 432 hours
Time to Maximum 0served Concentration (Tmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Time frame: From 0 to 432 hours
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Area Under the Concentration-Time Curve From Time 0 to 432 Hours AUC(0-432), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Time frame: From 0 to 432 hours
Terminal Elimination Half-Life (t1/2), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Time frame: From 0 to 432 hours
The incidence of Adverse events
The incidence and grading of adverse events
Time frame: From signing ICF until 14 days after departure from the study.