Clinical trial NCT05109832: A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Impact Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax (Maximum concentration)
timeFrame: 3 months
measure: Tmax
timeFrame: 3 months
measure: AUC0-inf (Area under the curve from time 0 to infinity)
timeFrame: 3 months
measure: AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)
timeFrame: 3 months
measure: t½ (Elimination half-life)
timeFrame: 3 months
measure: CL/F (Apparent clearance)
timeFrame: 3 months
measure: Vz/F (apparent volume of distribution )
timeFrame: 3 months
measure: urine and fecal samples for quantification analysis
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: