In this study, a single dose of \[14C\] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \[14C\] HDM002.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administered orally
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGTotal recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002
Total recovery of radioactivity in urine and feces, and both routes combined expressed as a percentage of the total radioactive dose administered
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Metabolite profiling/identification in plasma, urine, and feces
Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-06882961 and the metabolites of \[14C\] HDM1002 in plasma, urine, and feces.
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood AUC[0-t] of radioactivity
PK parameter : Area under the curve from time 0 to t hour
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood AUC[0-∞] of radioactivity
PK parameter : Area under the curve from time 0 hour to ∞
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Cmax of radioactivity
PK parameter : Maximum observed concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Tmax of radioactivity
PK parameter : Time to maximum plasma concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood t1/2 of radioactivity
PK parameter: Half life
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
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Plasma and whole blood CL/F of radioactivity
PK parameter : Apparent Clearance
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Vz/F of radioactivity
PK parameter : Apparent volume of distribution
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Percentage of plasma HDM1002 and metabolites in total plasma radioactivity
Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma AUC[0-t] of HDM1002 and metabolites
PK parameter : Area under the curve from time 0 to t hour
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma AUC[0-∞] of HDM1002 and metabolites
PK parameter : Area under the curve from time 0 hour to ∞
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Cmax of HDM1002 and metabolites
PK parameter : Maximum observed concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Tmax of HDM1002 and metabolites
PK parameter : Time to maximum plasma concentration
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma t1/2 of HDM1002 and metabolites
PK parameter: Half life
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma CL/F of HDM1002 and metabolites
PK parameter : Apparent Clearance
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Vz/F of HDM1002 and metabolites
PK parameter : Apparent volume of distribution
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Adverse events (AEs)
Number of subjects reporting AEs
Time frame: Predose up to Day 11 after administration of [14C] HDM1002