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NCT Number: NCT07411742

Mass Balance Study of [14C] D-2570

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mass Balance Study

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C] D-2570 group

Drug

[14C] labeled D-2570

Primary outcomes

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

  3. Total Radioactivity of D-2570 in Plasma and Whole Blood

    Time frame: baseline to 2 weeks

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

    Time frame: Baseline to 2 weeks

Secondary outcomes

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

    Time frame: Baseline to 3 weeks

  2. Blood concentration of D-2570

    Time frame: Baseline to 2 weeks

  3. Blood concentration of D-2570 metabolites (if applicable)

    Time frame: Baseline to 2 weeks

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

Mass Balance Study of [14C] D-2570 in Chinese Healthy Adult Male Subjects

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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