Fluid Retention Due to Heart Failure
Conditions
Brief summary
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
Interventions
DRUG[14C]HRS-9057
\[14C\]HRS-9057
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Informed consent was obtained voluntarily 2. Healthy males aged 18 \~ 45 years (inclusive) 3. Body weight ≥50 kg, BMI 19 \~ 28 kg/m2 (inclusive) 4. Adopt efficient contraceptive measures
Exclusion criteria
1. Have a history of drug allergy, specific allergy, or allergic constitution 2. 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 3. Have a history of risk factors for torsade de pointes 4. 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 5. During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms 6. Chest X-ray findings deemed clinically significant by the investigator 7. Have positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or treponema pallidum antibody or nonnegative test result for human immunodeficiency virus (HIV) during the screening period 8. Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing 9. Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration 10. All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea 11. Workers engaged in conditions requiring long-term exposure to radioactivity; Or had significant radiation exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations) within 1 year before the trial or had participated in a radiolabeled drug trial within 1 year 12. Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period | From Day 1 to Day 28 |
| Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC) | From Day 1 to Day 8 |
| The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose) | From Day 1 to Day 28 |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax | From Day 1 to Day 28 |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax | From Day 1 to Day 28 |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2 | From Day 1 to Day 28 |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT | From Day 1 to Day 28 |
| Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC | From Day 1 to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax | From Day 1 to Day 28 |
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax | From Day 1 to Day 28 |
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2 | From Day 1 to Day 28 |
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT | From Day 1 to Day 28 |
| Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC | From Day 1 to Day 28 |
| Serious adverse events | From ICF signing date to Day 28 |
Countries
China
Outcome results
None listed