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NCT Number: NCT05109832

A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects

A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects

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Key information

Conditions

Solid Tumor

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

About this study

Study design A Phase I, single-center, open-label, single arm study is designed to evaluate Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects.

6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Volunteers must meet all of the following inclusion criteria to be included in the study:
  • Volunteers must fully understand the objective, nature, methods and possible adverse reactions of the trial, volunteer to be volunteers, and sign an informed consent form before the start of any study procedures, and at the same time guarantee that the volunteers will personally participate in the study during any procedures.
  • Chinese healthy male volunteers aged between 18 and 55 (including cut-off values) at the time of screening.
  • Volunteers with a body mass index (BMI) of 18.0-28.0 kg/m2 (including cut-off values), and a body weight of ≥ 50.0 kg.

Exclusion criteria

  • Volunteers who meet any of the following criteria cannot be included in this study:
  • Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bones.
  • A history of allergic diseases (including drug allergies and food allergies, etc.).
  • A history of any gastrointestinal diseases that will affect drug absorption such as dysphagia, irritable bowel syndrome, and inflammatory bowel disease; active hemorrhoids or perianal diseases accompanied by regular/current blood in the stool; habitual constipation or diarrhea.
  • Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, metabolism, or excretion.
  • Those who cannot tolerate venipuncture, and those who have a history of needke sickness and blood phobia.

Treatment and study plan

14C-IMP4297

Drug

14C marked IMP4297

Primary outcomes

  1. Cmax (Maximum concentration)

    Time frame: 3 months

    peak concentration

  2. Tmax

    Time frame: 3 months

    Time to peak

  3. AUC0-inf (Area under the curve from time 0 to infinity)

    Time frame: 3 months

    area under the curve from time zero to infinity

  4. AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)

    Time frame: 3 months

    AUC0-last area under the curve from time zero to the time with the last quantifiable concentration

  5. t½ (Elimination half-life)

    Time frame: 3 months

    elimination half-life

  6. CL/F (Apparent clearance)

    Time frame: 3 months

    apparent clearance

  7. Vz/F (apparent volume of distribution )

    Time frame: 3 months

    apparent volume of distribution

  8. urine and fecal samples for quantification analysis

    Time frame: 3 months

    Assessment of recovery percent in urine and feces by liquid chromatography-radiochemical-detection。 Get Percent (%) of each radiolabeled drug-related material will be determined in urine and feces

  9. After oral administration of [14C] IMP4297 in healthy volunteers, radioactive metabolite spectrogram are obtained to identify the main metabolites and clarify the main biotransformation pathways.

    Time frame: 3 months

    Proportion of different metabolites，Assessment of metabolites (metabolites identification and main metabolites) in plasma/urine/faeces by liquid chromatography-radiochemical-detection

Sponsors and collaborators

Lead sponsor

Impact Therapeutics, Inc.

Industry

Registry information

Official study title

A Clinical Trial of the Absorption, Metabolism, and Excretion of [14C]IMP4297 in Chinese Adult Male Healthy Volunteers - A Human Material Balance and Biotransformation Study of [14C]IMP4297

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2021
Registry last updated
Sep 16, 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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