This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Subjects will receive single dose of orally \[14C\]HRS-8080.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The cumulative amount of HRS-8080 excreted.
Time frame: 0 hour to 360 hours.
Percentage of parent drug and its metabolite(s) relative to total radioactive exposure in plasma.
Time frame: 0 hour to 360 hours.
Percentage of administered dose excreted as parent drug and its metabolite(s) in urine.
Time frame: 0 hour to 360 hours.
Percentage of administered dose excreted as parent drug and its metabolite(s) in feces.
Time frame: 0 hour to 360 hours.
Maximum concentration (Cmax).
Pharmacokinetic parameters for total radioactivity in plasma.
Time frame: 0 hour to 336 hours.
Time of maximum concentration (Tmax).
Pharmacokinetic parameters for total radioactivity in plasma.
Time frame: 0 hour to 336 hours.
Area under the concentration-time curve (AUC).
Pharmacokinetic parameters for total radioactivity in plasma.
Time frame: 0 hour to 336 hours.
Elimination half-life (t1/2).
Pharmacokinetic parameters for total radioactivity in plasma.
Time frame: 0 hour to 336 hours.
Apparent clearance (CL/F).
Pharmacokinetic parameters for total radioactivity in plasma.
Time frame: 0 hour to 336 hours.
Apparent volume of distribution (Vz/F).
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Pharmacokinetic parameters for total radioactivity in plasma.
Time frame: 0 hour to 336 hours.
Ratio of total radioactivity in whole blood to plasma.
Time frame: 0 hour to 360 hours.
Maximum concentration (Cmax).
Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.
Time frame: 0 hour to 336 hours.
Time of maximum concentration (Tmax).
Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.
Time frame: 0 hour to 336 hours.
Area under the concentration-time curve (AUC).
Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.
Time frame: 0 hour to 336 hours.
Elimination half-life (t1/2).
Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.
Time frame: 0 hour to 336 hours.
Apparent clearance (CL/F).
Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.
Time frame: 0 hour to 336 hours.
Apparent volume of distribution (Vz/F).
Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.
Time frame: 0 hour to 336 hours.
Adverse events (AEs).
Time frame: Day -7 to Day 23.