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

NCT ID: NCT05109832

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-09
• Study Completion Date: 2021-12-06

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

Detailed Description

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)

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

14C-IMP4297

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

Group Type: EXPERIMENTAL

14C-IMP4297

Intervention Type: DRUG

14C marked IMP4297

Interventions

14C-IMP4297

14C marked IMP4297

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Chinese healthy male volunteers aged between 18 and 55 (including cut-off values) at the time of screening.

3. 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:

1. 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.

2. A history of allergic diseases (including drug allergies and food allergies, etc.).

3. 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.

4. 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.

5. Those who cannot tolerate venipuncture, and those who have a history of needke sickness and blood phobia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Impact Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

IMP4297-109

Identifier Type: -

Identifier Source: org_study_id