Study of \[14C\]CS0159 in China Healthy Subjects.
A phase I study to quantify the total mass balance in healthy subjects after a single dose of \[14C\]CS0159.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
Single oral administration of 4mg \[14C\]CS0159
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Mass Balance
Mass balance recovery of total radioactivity in urine and fecal samples.
Time frame: Screening period (-48 hours) to 240 hours
[14C] CS0159 metabolite
Identification of the major metabolites of CS0159 in human plasma, urine and faeces, determine the main Determine the main biotransformation pathways and calculate the percentage of the administered dose of the prodrug and each metabolite in urine and faeces, and plasma prodrugs and circulating metabolites as a percentage of total exposure AUC.
Time frame: Screening period (-48 hours) to 240 hours
Radioactivity of CS0159
Whole blood to plasma total radioactivity ratio
Time frame: Up to 90 hours post dose
Area under the curve
Total radioactivity in plasma PK: AUC
Time frame: Up to 90 hours post dose
Highest radioactivity observed plasma concentration
Total radioactivity in plasma PK: Cmax
Time frame: Up to 90 hours post dose
Time for Cmax
Total radioactivity in plasma PK: Tmax
Time frame: Up to 90 hours post dose
Elimination half-life
Total radioactivity in plasma PK: T1/2
Time frame: Up to 90 hours post dose
Blood plasma PK
other major metabolites in plasma( if any).
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Time frame: Up to 90 hours post dose
Adverse events
All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs
Time frame: Up to 240 hours post dose
AUC of CS0159
Area under the plasma concentration time curve of CS0159
Time frame: Up to 90 hours post dose
Cmax of CS0159
Highest observed plasma concentration of CS0159
Time frame: Up to 90 hours post dose
T1/2 of CS0159
Elimination half-life of CS0159
Time frame: Up to 90 hours post dose
Tmax of CS0159
Time for Cmax of CS0159
Time frame: Up to 90 hours post dose