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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: 14C-IMP4297

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)

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Daisy Wang; Phone Number: 86 13816512953; Email: daisy.wang@impacttherapeutics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14C-IMP4297; In this study, one 100 mg dose of 14C IMP4297 Oral Suspension, 100 mg (100 μCi).	Drug: 14C-IMP4297; 14C marked IMP4297

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum concentration)	peak concentration	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
AUC0-inf (Area under the curve from time 0 to infinity)	area under the curve from time zero to infinity	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
Tmax	Time to peak	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

Collaborators and Investigators

• Sponsor: Impact Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IMP4297-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No