About this trial
This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Informed consent was obtained voluntarily
Healthy males aged 18 ~ 45 years (inclusive)
Body weight ≥50 kg, BMI 19 ~ 28 kg/m2 (inclusive)
Adopt efficient contraceptive measures
Disqualifiers
Have a history of drug allergy, specific allergy, or allergic constitution
Any previous or current medical history that may affect the safety of the participant in the trial or the course of the study drug in vivo
Have a history of risk factors for torsade de pointes
During the screening period, serum potassium, sodium, ALT, or AST were beyond the normal range, or the calculated eGFR was less than 90 mL/min/1.73m2
Trial design
Single group
Treatments tested in this trial
[14C]HRS-9057
Drug\[14C\]HRS-9057
Treatment groups
Trial outcomes
Primary outcomes
Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period
Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC)
The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose)
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax
Secondary outcomes
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: