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NCT Number: NCT05802810

The Mass Balance Study of [14C]JT001

This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of [14C]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult males
  • Age: 18-45 years old
  • Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg;
  • Voluntarily sign informed consent;
  • Subjects were able to complete the trail according to protocol.

Exclusion criteria

  • Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant
  • The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease
  • Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive;
  • Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period
  • Any conditions that may affect drug absorption.
  • Previous antineoplastic therapy meets washout requirements.
  • Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
  • Habitual constipation or diarrhea.
  • Significant radioactive exposure within 1 year.

Treatment and study plan

[14C]JT001

Drug

Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally.

Primary outcomes

  1. Total radioactive recovery

    Time frame: 1 month

    The percentage of radioactivity recovered from collected samples

  2. cumulative excretion rate of total radioactive material in fecal matter

    Time frame: 1 month

    After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces

  3. Peak concentration（Cmax）

    Time frame: 1 month

    The highest plasma drug concentration that can be achieved after medication

  4. time to peak（Tmax）

    Time frame: 1 month

    After a single dose, the time of peak blood concentration

  5. elimination half life（t1/2）

    Time frame: 1 month

    the time it takes the blood to reduce the concentration of the drug to half

  6. Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS)

    Time frame: 1 month

    The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: 2 month

    Number of cases and incidence of adverse events(AEs)

Sponsors and collaborators

Lead sponsor

Shanghai Vinnerna Biosciences Co., Ltd.

Industry

Collaborators

  • Sponsor GmbH

Registry information

Official study title

The Mass Balance Study of [14C]JT001 in Chinese Healthy Adult Male Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Jun 22, 2025

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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