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

NCT05109832 | Completed Phase 1

• 1 other identifier: IMP4297-109
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (9)

• Cmax (Maximum concentration)

  peak concentration

  3 months

• Tmax

  Time to peak

  3 months

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

  area under the curve from time zero to infinity

  3 months

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

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

  3 months

• t½ (Elimination half-life)

  elimination half-life

  3 months

• CL/F (Apparent clearance)

  apparent clearance

  3 months

• Vz/F (apparent volume of distribution )

  apparent volume of distribution

  3 months

• urine and fecal samples for quantification analysis

  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

  3 months

• 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.

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

  3 months

Study Arms (1)

14C-IMP4297

EXPERIMENTAL

In this study, one 100 mg dose of 14C IMP4297 Oral Suspension, 100 mg (100 μCi).

Drug: 14C-IMP4297

Interventions

14C-IMP4297 DRUG

14C marked IMP4297

14C-IMP4297

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 5, 2021
• Study Start: October 9, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)