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Breast CancerPhase 1NCT06149611

Mass Balance Study of TQB3616

A Phase 1 study testing [14C] TQB3616 in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
[14C] TQB3616
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
Jan 2024to Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Liyan Miao, Master of Medicine contact

13862592687

miaolysuzhou@163.com

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Liyan Miao, Master of Medicine, 13862592687, miaolysuzhou@163.com

Other trials in China

About this study

Official title: Clinical Study on Material Balance of [14C]TQB3616 in Healthy Chinese Subjects

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.

Conditions
Breast Cancer
Being tested
[14C] TQB3616
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C] TQB3616Drug

    TQB3616 is a new type of cyclin-dependent kinase (CDK) 4/6 inhibitor.

Study groups in NCT06149611
Study groupRoleWhat they receive
[14C] TQB3616Experimental100 µCi [14C] TQB3616, 180mg, once in total.
Receives: Drug: [14C] TQB3616

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak concentration (Cmax)

    Maximum plasma drug concentration

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after dose.

  2. Area under drug time curve

    Area under the blood concentration time curve

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after dose.

  3. Time to peak concentration (Tmax)

    Time to reach maximum (peak) plasma concentration following drug administration

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after dose.

  4. Elimination half-life (t1/2)

    The time it takes for the blood concentration of a drug to decrease from its highest value to half in the body.

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after dose.

  5. Mean resident time (MRT)

    The average time that drug molecules remain in the body.

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after dose.

Secondary outcomes (1)

  1. Adverse event rate

    The incidence of adverse events after administration.

    Measured: Baseline up to 21 days after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06149611
Sponsor's protocol ID
TQB3616-I-04
Status last verified
Nov 2023
First submitted
21 Nov 2023
Last updated
29 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C] TQB3616 in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liyan Miao, Master of Medicine (13862592687, miaolysuzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak concentration (Cmax) (time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after dose.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06149611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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