Trial Title:
Mass Balance Study of TQB3616
NCT ID:
NCT06149611
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[14C] TQB3616
Description:
TQB3616 is a new type of cyclin-dependent kinase (CDK) 4/6 inhibitor.
Arm group label:
[14C] TQB3616
Summary:
This is a clinical study exploring the mass balance of [14C] TQB3616 in healthy Chinese
subjects aims to quantitatively analyze the total radioactivity in the feces of male
healthy subjects after oral administration of [14C] TQB3616, obtain data on human
radiation excretion rate and main excretion pathways, investigate the distribution in
whole blood and plasma, plasma distribution, and pharmacokinetics of total radioactivity
in plasma, identify main metabolites, and determine the main biological transformation
pathways, obtain the pharmacokinetic parameters of TQB3616 and its metabolites in plasma.
The primary endpoint is mass balance, radiopharmacokinetics, plasma pharmacokinetics, and
metabolites.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Healthy adult male;
- Age: 18-45 years old (inclusive);
- The body mass index (BMI) is between 19-26 kg/m2 (inclusive), and the subject's body
weight shall be not less than 50 kg (inclusive);
- Voluntarily sign the informed consent form;
- The subjects are able to communicate well with the investigators and complete the
study according to the protocol.
Exclusion Criteria:
- Abnormal and clinically significant results in comprehensive physical examination,
vital signs, digital examination of the anus, laboratory examination (blood routine,
blood biochemistry, urine routine, coagulation function, fecal routine+occult blood,
thyroid function, etc.), 12-lead electrocardiogram, chest X-ray
(Posterior-anterior), abdominal ultrasound (liver, gallbladder, pancreas, spleen,
kidney), ect.;
- Abnormal and clinically significant results in ophthalmic examinations (slit lamp,
intraocular pressure, and fundus photography);
- Any one of hepatitis B surface antigen, hepatitis B e antigen, hepatitis C antibody,
HIV antibody and syphilis antibody is positive;
- Within 30 days before the screening period, those who have used any drugs that
inhibit or induce liver drug metabolism (such as CYP3A4 inducers like carbamazepine,
dexamethasone, rifampicin, phenytoin, phenobarbital, rifabutin, rifapentine,
hypericum perforatum, etc.; CYP3A4 inhibitors like itraconazole, ketoconazole,
clarithromycin, voriconazole, telithromycin, saquinavir, lopinavir, ritonavir,
etc.);
- Within 14 days prior to the screening period, have taken any prescription drugs,
over-the-counter drugs, Chinese herbal medicines, or health products;
- Those who have participated in any drug clinical trial and received any
investigational drug within 3 months prior to the screening period;
- Have a history of any clinically serious illness or condition that the investigator
believes may affect the test results, including but not limited to a history of
circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and
metabolic diseases;
- Having undergone major surgery or incomplete healing of the surgical incision within
6 months prior to the screening period; Major surgeries include, but are not limited
to, any surgeries with significant bleeding risks, prolonged general anesthesia, or
open biopsies or obvious traumatic injuries.
- Individuals with allergic constitution, including those with a history of drug
allergy, known to be allergic to TQB3616 or similar drugs or its excipients, be
allergic to any food ingredient or has special dietary requirements, and cannot
follow a unified diet;
- Hemorrhoids or perianal diseases with regular/ongoing bloody stools; The presence of
gastrointestinal dysfunction such as irritable bowel syndrome and inflammatory bowel
disease that may affect drug absorption, distribution, metabolism, and excretion, as
determined by investigators;
- Habitual constipation or diarrhea;
- Excessive drinking or frequent drinking within 6 months prior to the screening
period, i.e. drinking more than 14 units of alcohol per week (1 unit=360 mL of beer
or 45 mL of 40% alcohol or 150 mL of wine); Or during the screening period, the
alcohol breath test result is ≥ 20 mg/dL;
- Those who smoke more than 5 cigarettes per day or habitually use nicotine containing
products within 3 months prior to the screening period, and are unable to quit
during the trial period;
- Abuse of drugs or use of soft drugs (such as marijuana) within 3 months prior to the
screening period, or use of hard drugs (such as cocaine, amphetamines,
phencyclidine, etc.) within 1 year prior to the screening period; Positive urine
drug abuse test during screening period;
- Habitually drinking grapefruit juice or excessive amounts of tea, coffee, and/or
caffeinated beverages, and unable to quit during the study period;
- Engaged in working that require long-term exposure to radioactive conditions; Or
those who have significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥ 3
other types of X-ray examinations) or participated in radiopharmaceutical labeling
tests within 1 year before the study;
- Those who have received vaccines within 1 month before screening or have vaccination
plans during the study;
- Individuals with a history of needle or blood fainting and have difficulty or cannot
tolerate venous puncture for blood collection;
- Those who have fertility plans during the study period and within 1 year after the
completion of the study; or those who do not agree to adopt strict contraceptive
measures during the experiment and within 1 year after the completion of the study;
- Individuals who have experienced blood loss or donated up to 400 mL of blood within
3 months prior to the screening period, or have received blood transfusions, or plan
to donate blood within 1 month after the end of this study;
- Subjects that are not suitable for participating in this study due to other factors
as judged by the investigators.
Gender:
Male
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Contact:
Last name:
Liyan Miao, Master of Medicine
Phone:
13862592687
Email:
miaolysuzhou@163.com
Start date:
January 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149611
