Mass Balance Study
Conditions
Brief summary
Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated through extensive human trials. The primary objectives of this study are as follows: To quantitatively analyze the total radioactive activity (TRA) in urine and feces, thereby determining the radioactive recovery rate in humans and identifying the primary excretion pathways. To obtain radioactive metabolite profiles in human plasma, urine, and feces, identify the major metabolites, and determine the principal metabolic and elimination pathways. To quantitatively analyze the total radioactive activity in whole blood and plasma, derive the pharmacokinetic parameters for total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity between whole blood and plasma.
Interventions
DRUG[14C] D-2570 group
\[14C\] labeled D-2570
Sponsors
InventisBio 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
* The subject must voluntarily participates in this study after full informed consent. * Chinese male healthy subjects aged 18-45 years (inclusive) at the time of signing the ICF * At screening, subject's body weight is ≥50.0 kg, with a body mass index (BMI) between 19.0 kg/m² and 26.0 kg/m² (inclusive) * Subjects have no plans for reproduction or sperm donation during the trial and for 6 months after study drug administration. Subjects agree to practice complete abstinence, have undergone sterilization surgery, or agree to use effective contraception from the time of ICF signing throughout the entire study period until 6 months after study drug administration.
Exclusion criteria
* Findings from screening assessments judged by the investigator as abnormal and clinically significant * History of infection as defined in the protocol. * Any of the medical diseases or disorders listed in the protocol. * Unable to comply with the lifestyle restrictions stipulated in the protocol. * Medication history does not meet the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose | 2 weeks |
| Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug) | 2 weeks |
| Total Radioactivity of D-2570 in Plasma and Whole Blood | baseline to 2 weeks |
| Whole blood/plasma ratio for TRA (total radioactivity) at different time points | Baseline to 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs based on NCI CTCAE V6.0 | Baseline to 3 weeks |
| Blood concentration of D-2570 | Baseline to 2 weeks |
| Blood concentration of D-2570 metabolites (if applicable) | Baseline to 2 weeks |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMeng Wang
Second Affiliated Hospital of Soochow University
Outcome results
None listed