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

IMPACT Therapeutics

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: 14C-IMP4297

Study type

Interventional

Funder types

Industry

Identifiers

NCT05109832

IMP4297-109

Details and patient eligibility

About

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

Full 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)

Enrollment

6 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Volunteers must meet all of the following inclusion criteria to be included in the study:
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.