Mass Balance Study of [14C] D-2570

Phase 1Active Not RecruitingNCT07411742

InventisBio Co., Ltd8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Mass Balance Study

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose

Time frame: 2 weeks

Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug)

Time frame: 2 weeks

Total Radioactivity of D-2570 in Plasma and Whole Blood

Time frame: baseline to 2 weeks

Whole blood/plasma ratio for TRA (total radioactivity) at different time points

Time frame: Baseline to 2 weeks

Secondary Outcomes

Incidence and severity of AEs based on NCI CTCAE V6.0

Time frame: Baseline to 3 weeks

Blood concentration of D-2570

Time frame: Baseline to 2 weeks

Blood concentration of D-2570 metabolites (if applicable)

Time frame: Baseline to 2 weeks

Mass Balance Study of [14C] D-2570

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes