CompletedPhase 1

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

China6 participantsStarted 2021-10-09

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

✕. 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.
✕. A history of allergic diseases (including drug allergies and food allergies, etc.).
✕. 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.
✕. 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.
✕. Those who cannot tolerate venipuncture, and those who have a history of needke sickness and blood phobia.

What they're measuring

Cmax (Maximum concentration)

Timeframe: 3 months

Tmax

Timeframe: 3 months

AUC0-inf (Area under the curve from time 0 to infinity)

Timeframe: 3 months

AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)

Timeframe: 3 months

t½ (Elimination half-life)

Timeframe: 3 months

CL/F (Apparent clearance)

Timeframe: 3 months

Vz/F (apparent volume of distribution )

Timeframe: 3 months

urine and fecal samples for quantification analysis

Timeframe: 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.

Trial details

NCT IDNCT05109832

SponsorImpact Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-06

View on ClinicalTrials.gov More Solid Tumor trials

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

✕. 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.
✕. A history of allergic diseases (including drug allergies and food allergies, etc.).
✕. 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.
✕. 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.
✕. Those who cannot tolerate venipuncture, and those who have a history of needke sickness and blood phobia.

What they're measuring

Cmax (Maximum concentration)

Timeframe: 3 months

Tmax

Timeframe: 3 months

AUC0-inf (Area under the curve from time 0 to infinity)

Timeframe: 3 months

AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)

Timeframe: 3 months

t½ (Elimination half-life)

Timeframe: 3 months

CL/F (Apparent clearance)

Timeframe: 3 months

Vz/F (apparent volume of distribution )

Timeframe: 3 months

urine and fecal samples for quantification analysis

Timeframe: 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.