This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]GP681 in healthy Chinese male volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and providing a reference for the rational administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
40 mg suspension containing 100μCi of \[14C\]GP681
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
The distribution of GP681 in the whole blood and plasma, and the radioactive pharmacokinetics following the single orally administered [14C]GP681 in healthy Chinese male volunteers.
The percentage of radioactive dose of \[14C\] radiolabelled GP681 recovered in blood and in total.
Time frame: Up to 336 hours (approx) from the start of administration.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]GP681 in healthy Chinese male subjects to obtain the mass balance data and the main excretion pathway in human body.
The percentage of radioactive dose of \[14C\] radiolabelled GP681 recovered in urine, faeces and in total.
Time frame: Up to 432 hours (approx) from the start of administration.
Quantitive analysis of the concentrations of GP681 and its major metabolites (such as GP1707D07) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
The concentrations of GP681 and its major metabolites in plasma.
Time frame: Up to 336 hours (approx) from the start of administration.
Identification of the main metabolites and biotransformation pathway of GP681 following the single orally administered [14C]GP681 in healthy Chinese male volunteers
Proportion of different metabolites.
Time frame: Up to 432 hours (approx) from the start of administration.
Evaluation of safety following the single orally administered [14C]GP681 in healthy Chinese male volunteers.
Adverse events assessed by NCI-CTCAE v5.0.
Time frame: Up to 432 hours (approx) from the start of administration.
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