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Completed

NCT Number: NCT05920941

Mass Balance Study of [14C]JAB-21822

Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects

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Key information

Conditions

Mass Balance Study in 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, 215000, China

About this study

A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]JAB-21822

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects between the ages of 18 and 45 years (inclusive).
  • Subjects weighing ≥ 50 kg and Body Mass Index of 19.0 to 26.0 kg/m2.
  • Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.

Exclusion criteria

  • With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations.
  • Has a positive test for HBV, HCV, HIV, or syphilis.
  • Known medical history judged by the investigator as not suitable for the study.
  • Known history of drug or food allergy.
  • Has drug or alcohol abuse history or positive drug or alcohol abuse test results.
  • Heavy smokers or caffeine addicts.
  • Has diseases or other conditions affecting the absorption, distribution, metabolism, and excretion of oral drugs.
  • Disagree to strict contraception within one year after the trial
  • Has any other conditions judged by the investigator as not suitable for the study.

Treatment and study plan

[14C]JAB-21822

Drug

Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach

Primary outcomes

  1. Recovery of total radioactivity in urine and fecal samples

    Time frame: up to 504 hours post dose

    Mass balance recovery of total radioactivity in urine and fecal samples

  2. Total radioactivity in plasma PK: Cmax

    Time frame: up to 504 hours post dose

    Highest radioactivity observed plasma concentration

  3. Total radioactivity in plasma PK: Area under the curve

    Time frame: up to 504 hours post dose

    Area under the plasma concentration time curve

  4. Total radioactivity in plasma PK: t1/2

    Time frame: up to 504 hours post dose

    Elimination half-life

  5. Total radioactivity in plasma PK: MRT

    Time frame: up to 504 hours post dose

    Mean residence time

  6. Total radioactivity in plasma PK: Tmax

    Time frame: up to 504 hours post dose

    Time for Cmax

  7. Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples

    Time frame: up to 504 hours post dose

    Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites

  8. Whole blood to plasma total radioactivity ratio

    Time frame: up to 504 hours post dose

Secondary outcomes

  1. JAB-21822 PK: Cmax

    Time frame: up to 504 hours post dose

    Highest observed plasma concentration of JAB-21822

  2. JAB-21822 PK: Area under the curve

    Time frame: up to 504 hours post dose

    Area under the plasma concentration time curve of JAB-21822

  3. JAB-21822 PK: t1/2

    Time frame: up to 504 hours post dose

    Elimination half-life of JAB-21822

  4. JAB-21822 PK: MRT

    Time frame: up to 504 hours post dose

    Mean residence time of JAB-21822

  5. JAB-21822 PK: Tmax

    Time frame: up to 504 hours post dose

    Time for Cmax of JAB-21822

  6. Number of participants with adverse events

    Time frame: up to 504 hours post dose

    All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and ophthalmological assessments

Sponsors and collaborators

Lead sponsor

Allist Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Apr 4, 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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