Healthy Subjects
Conditions
Keywords
Phase I, Mass balance, HS-10504, Healthy participants
Brief summary
This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of \[14C\] HS-10504 in healthy adult male subjects.
Interventions
DRUG[¹⁴C]HS-10504
\[¹⁴C\]HS-10504: Participants will receive a single oral administration of approximately 400 mg/200 μCi \[¹⁴C\]HS-10504 under fasting conditions on day 1 morning.
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must be healthy adult males. 2. Aged 18 years or older. 3. BMI between 19.0 and 26.0 kg/m² (inclusive) and weight no less than 50 kg (inclusive). 4. Able and willing to provide written informed consent voluntarily.
Exclusion criteria
1. Clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, thyroid function, coagulation function, urinalysis, stool routine and occult blood), 12-lead electrocardiogram, ophthalmic examination (slit lamp, intraocular pressure, and fundus photography), chest X-ray (posteroanterior view), digital rectal examination, abdominal ultrasound (liver, gallbladder, pancreas, and spleen), urinary system ultrasound (kidney, ureter, bladder, and prostate), echocardiography, etc.; 2. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (except topical agents with local effects) within 30 days prior to screening, or use of any drug with a washout period of less than 7 half-lives (whichever is longer) before screening; 3. Participation in other clinical trials and use of other investigational drugs or devices within 3 months prior to screening or during the screening period, or planned participation in another clinical trial during this study; 4. History of any clinically significant disease or condition that may affect the study results, as judged by the investigator, including but not limited to cardiovascular, respiratory, endocrine, neurological, digestive, urinary, or hematological, immune, psychiatric, or metabolic diseases; or onset of a new illness before study drug administration that is considered by the investigator to make the subject unsuitable for participation; 5. Major surgery within 6 months prior to screening, or a surgical incision that has not completely healed; 6. Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a hazard to the participant; 7. Predisposition to allergic reactions, or allergic constitution (e.g., allergy to pollen, any drugs/foods), or history of severe allergy; 8. Lactose intolerance; 9. Habitual constipation or diarrhea; 10. Frequent alcohol consumption within 3 months prior to screening, or inability to abstain from alcohol products during hospitalization; or a positive alcohol breath test at screening; 11. Average daily cigarette consumption \>5 cigarettes or habitual use of nicotine-containing products within 3 months prior to screening, or inability to abstain from any tobacco products during hospitalization; 12. Drug abuse, or use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., amphetamines, phencyclidine, etc.) within 1 year prior to screening; or a positive urine drug abuse (illicit drug) test at screening; 13. Employment in occupations requiring long-term exposure to radioactive conditions; or significant radiation exposure within 1 year prior to the study, or participation in radiopharmaceutical labeling studies within 1 year prior to the study; 14. Vaccination within 1 month prior to screening, or planned vaccination during the study; 15. History of syncope due to needle or blood, difficulty in blood sampling, or intolerance to venipuncture; 16. Plans to father a child or donate sperm (for male participants) from signing of informed consent to 1 year after study completion, or unwillingness to adopt strict contraceptive measures with their spouse/partner during this period; 17. Blood loss ≥400 mL or blood donation within 3 months prior to screening; or blood loss ≥200 mL within 1 month; or blood transfusion within 1 month; or planned blood donation within 3 months after study completion; 18. Special dietary requirements that cannot be complied with the standardized diet; 19. Other reasons judged by the investigator as unsuitable for participation, or withdrawal of the participant's own accord.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total radiorecovery and cumulative radiorecovery in urine and feces per time interval. | All excreted urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection. | To assess the routes and rates of elimination of HS-10504 and its metabolites after single oral administration of \[14C\]HS-10504 in healthy adult male participants. |
| Percentage of major metabolites in human plasma, urine, and feces. | Plasma, urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection. | To determine the metabolism and elimination pathways of HS-10504 after single oral administration of \[14C\]HS-10504 in healthy adult male subjects, and identify major metabolites. |
| The percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites (%AUC). | Plasma samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection. | To evaluate the percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites. |
| The percentage of the administered dose recovered as parent drug and metabolites in urine and feces | Urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection. | To evaluate the percentage of the administered dose recovered as parent drug and metabolites in urine and feces. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total radioactivity in human plasma and whole blood (if applicable) | From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection. | To evaluate total radioactivity in human plasma and whole blood (if applicable) |
| the concentration ratio of total radioactivity in whole blood to that in plasma at different time points. | From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection. | the concentration ratio of total radioactivity in whole blood to that in plasma at different time points. |
| Cmax | From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection. | To evaluate the Cmax of HS-10504 and its metabolite M6-2 in plasma. |
| Tmax | From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection. | To evaluate the Tmax of HS-10504 and its metabolite M6-2 in plasma. |
| AUC0-t | From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection. | To evaluate the AUC0-t of HS-10504 and its metabolite M6-2 in plasma. |
| AUC0-∞ | From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection. | To evaluate the AUC0-∞ of HS-10504 and its metabolite M6-2 in plasma. |
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | Up to end of the study, approximately 3 months | To assess the safety and tolerability of a single oral dose of approximately \[14C\] HS-10504 in healthy adult male subjects |
Outcome results
None listed