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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05109832
• Other study ID #: IMP4297-109
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 30, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2021
• Source: Impact Therapeutics, Inc.
• Contact: Daisy Wang
• Phone: 86 13816512953
• Email: daisy.wang[@]impacttherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: June 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 14C-IMP4297
14C marked IMP4297

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Impact Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (Maximum concentration)	peak concentration	3 months
Primary	Tmax	Time to peak	3 months
Primary	AUC0-inf (Area under the curve from time 0 to infinity)	area under the curve from time zero to infinity	3 months
Primary	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
Primary	t½ (Elimination half-life)	elimination half-life	3 months
Primary	CL/F (Apparent clearance)	apparent clearance	3 months
Primary	Vz/F (apparent volume of distribution )	apparent volume of distribution	3 months
Primary	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
Primary	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