Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
8 participants
INTERVENTIONAL
2024-01-31
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
[14C] TQB3616
100 µCi \[14C\] TQB3616, 180mg, once in total.
[14C] TQB3616
TQB3616 is a new type of cyclin-dependent kinase (CDK) 4/6 inhibitor.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[14C] TQB3616
TQB3616 is a new type of cyclin-dependent kinase (CDK) 4/6 inhibitor.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Liyan Miao, Master of Medicine
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TQB3616-I-04
Identifier Type: -
Identifier Source: org_study_id