Recurrent/Metastatic Breast CancerPhase 1NCT05344729
Clinical Trial for Effect of TQB3616 Capsule on Pharmacokinetics in Healthy Adult Subjects
A Phase 1 study testing TQB3616 Capsule in people with Recurrent/Metastatic Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism of action is to inhibit the proliferation of tumor cells by reducing the phosphorylation level of retinoblastoma protein (Rb) in… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent/Metastatic Breast Cancer
- What is being tested?
- TQB3616 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2021to 30 Aug 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1 Sign the informed consent form before the trial and fully understand the content, process and possible adverse reactions of the trial;
- 2 Be able to complete the study according to the requirements of the study protocol;
- 3 Subjects aged 18 to 65 years (including 18 and 65 years);
- 4 Body mass index (BMI) ≥ 18 and ≤ 28 kg/m2, and male body weight ≥ 50 kg Female body weight ≥ 45 kg;
- 5 Health condition: no mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
- 6 Subjets had no plans to become pregnant and voluntarily took effective contraceptive measures from 2 weeks before dosing to at least 6 months after the last dose of study drug.
Who cannot join
- 1 Patients with a history of neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hemolymphatic, hepatic or renal insufficiency, endocrine, musculoskeletal system disease or other diseases, which may affect drug metabolism or safety as judged by the investigator;
- 2 Allergic constitution or previous history of two or more kinds of food or drug allergy;
- 3 Hyperactive/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;
- 4 Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal diseases);
- 5 Taking any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 1 month before taking the study drug;
- 6 Administration of CYP3A4 inhibitors or inducers within 1 month before screening or before study drug;
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- 7 Taking special diet (including grapefruit, etc.) or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 14 days before screening;
- 8 Abnormal and clinically significant laboratory findings during the screening period;
- 9 Blood donation or significant blood loss (> 450 mL) within 3 months prior to administration of study drug;
- 10 Participated in any drug clinical trial within 3 months before taking the study drug;
- 11 Smoking more than 5 cigarettes per day within 3 months before the trial;
- 12 Positive breath alcohol test or history of alcoholism (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine);
- 13 Drug screening positive or drug use 3 months before the trial;
- 14 Inability to tolerate venipuncture for blood sampling or poor vascular status;
- 15 Subjets cannot complete the trial due to personal reasons;
- 16 Other conditions considered inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130021
About this study
Official title: A Randomized, Open-label, Single-center, Two-period, Two-crossover Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3616 Capsules in Healthy Adult Subjects
TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism of action is to inhibit the proliferation of tumor cells by reducing the phosphorylation level of retinoblastoma protein (Rb) in cancer cells and blocking the progression of cells from G1 phase to S phase. This study is a randomized, open-label, single-center, two-period, two-crossover phase I clinical trial to assess the effect of food on the pharmacokinetics of TQB3616 capsules in healthy adult subjects, to evaluate the effect of food on the pharmacokinetics of TQB3616 capsules after oral administration in healthy adult Chinese subjects and to observe the safety of TQB3616 capsules after single oral administration in healthy subjects.Each subject will be randomly assigned to one of two groups (group A and B). A total of 16 subjects were enrolled, all taking TQB3616 capsules 180mg, including 8 subjects in group A and 8 subjects in group B. The study included screening period, randomization, first cycle, washout period and second cycle. The first cycle and second cycle each contained 3 return visits. 18 pharmacokinetic samples were collected every cycle for pharmacokinetic index analysis. Vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, adverse events, drug combination and non-drug therapy information were collected during the study to ensure the safety of the subjects.
- Conditions
- Recurrent/Metastatic Breast Cancer
- Being tested
- TQB3616 Capsule
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3616 CapsuleDrug
It inhibits the proliferation of tumor cells by reducing the level of retinoblastoma protein (Rb) phosphorylation in cancer cells and blocking the progression of cells from G1 to S phase.
| Study group | Role | What they receive |
|---|---|---|
| TQB3616 Capsule- Fasted+ TQB3616 Capsule- After meal | Experimental | Subjects in Arm A will take TQB3616 capsules under fasting and fed state in Cycle 1 and Cycle 2, respectively Receives: Drug: TQB3616 Capsule |
| TQB3616 Capsule- After meal + TQB3616 Capsule- Fasted | Experimental | Subjects in Arm B will take TQB3616 capsules in Cycle 1 and Cycle 2 under fasting state, respectively Receives: Drug: TQB3616 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration(Cmax)
Maximum plasma drug concentration
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Area under the time-concentration curve from 0 to t hours after drug administration(AUC0-t))
Area under the plasma concentration-time curve from the time of first dose to the time of the last measurable concentration
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Area under the time-concentration curve from 0 to infinity after drug administration(AUC0-∞)
Area under the plasma concentration-time curve from the time of first dosing extrapolated to infinity
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Secondary outcomes (12)
Time to peak(Tmax)
Time to reach maximum (peak) plasma concentration following drug administration
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Elimination half-life(t1/2)
Elimination half-life (to be used in one-or non-compartmental model)
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Apparent volume of distribution(Vd/F)
Apparent volume of distribution after non-intravenous administration
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Apparent clearance(CL/F)
Apparent total clearance of the drug from plasma after oral administration
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Bioavailability(F)
Bioavailability (systemic availability of the administered dose)
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Elimination rate constant (λz)
Terminal disposition rate constant/terminal rate constant
Measured: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Body temperature
Abnormal body temperature
Measured: The first and second cycles before adminisyration, 1, 2, 6, 8, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Pulse
Abnormal pulse
Measured: The first and second cycles before adminisyration, 1, 2, 6, 8, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Blood pressure
Abnormal blood pressure
Measured: The first and second cycles before adminisyration, 1, 2, 6, 8, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Physical examination
The doctor percusses, looks, and questions the subject
Measured: After the end of the first cycle and the second cycle (each cycle is 12 days)
Electrocardiogram QT interval
Safety Checks
Measured: After the end of the first cycle and the second cycle (each cycle is 12 days)
Adverse Events
Monitor the safety indicators of subjects during the trial
Measured: Up to 31 days (each cycle is 12 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start6 Jul 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent/Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344729
- Sponsor's protocol ID
- TQB3616-I-02
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dai J, Zhou Y, Zhang L, Ren Q, Liu Z, Wang Y, Cheng Y, Deng Q, Yang H, Zhang H. The food effect on the pharmacokinetics of TQB3616 capsule in Chinse healthy subjects: a randomized, open-label, single-center, two-period, two-sequence crossover phase I clinical trial. Front Pharmacol. 2025 May 30;16:1586368. doi: 10.3389/fphar.2025.1586368. eCollection 2025.
PubMed 40520159
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-center, Two-period, Two-crossover Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3616 Capsules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05344729
- Acronym / sponsor ID
- TQB3616-I-02
- Conditions
- Recurrent/Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism of action is to inhibit the proliferation of tumor cells by reducing the phosphorylation level of retinoblastoma protein (Rb) in cancer cells and blocking the progression of cells from G1 phase to S phase. This study is a randomized, open-label, single-center, two-period, two-crossover phase I clinical trial to assess the effect of food on the pharmacokinetics of TQB3616 capsules in healthy adult subjects, to evaluate the effect of food on the pharmacokinetics of TQB3616 capsules after oral administration in healthy adult Chinese subjects and to observe the safety of TQB3616 capsules after single oral administration in healthy subjects.Each subject will be randomly assigned to one of two groups (group A and B). A total of 16 subjects were enrolled, all taking TQB3616 capsules 180mg, including 8 subjects in group A and 8 subjects in group B. The study included screening period, randomization, first cycle, washout period and second cycle. The first cycle and second cycle each contained 3 return visits. 18 pharmacokinetic samples were collected every cycle for pharmacokinetic index analysis. Vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, adverse events, drug combination and non-drug therapy information were collected during the study to ensure the safety of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB3616 Capsule- Fasted+ TQB3616 Capsule- After meal | Experimental | Drug: TQB3616 CapsuleSubjects in Arm A will take TQB3616 capsules under fasting and fed state in Cycle 1 and Cycle 2, respectively |
| TQB3616 Capsule- After meal + TQB3616 Capsule- Fasted | Experimental | Drug: TQB3616 CapsuleSubjects in Arm B will take TQB3616 capsules in Cycle 1 and Cycle 2 under fasting state, respectively |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1 Sign the informed consent form before the trial and fully understand the content, process and possible adverse reactions of the trial;
- 2 Be able to complete the study according to the requirements of the study protocol;
- 3 Subjects aged 18 to 65 years (including 18 and 65 years);
- 4 Body mass index (BMI) ≥ 18 and ≤ 28 kg/m2, and male body weight ≥ 50 kg Female body weight ≥ 45 kg;
- 5 Health condition: no mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
Key exclusion criteria (16 listed)
- 1 Patients with a history of neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hemolymphatic, hepatic or renal insufficiency, endocrine, musculoskeletal system disease or other diseases, which may affect drug metabolism or safety as judged by the investigator;
- 2 Allergic constitution or previous history of two or more kinds of food or drug allergy;
- 3 Hyperactive/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;
- 4 Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal diseases);
- 5 Taking any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 1 month before taking the study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3616 CapsuleIt inhibits the proliferation of tumor cells by reducing the level of retinoblastoma protein (Rb) phosphorylation in cancer cells and blocking the progression of cells from G1 to S phase. | Drug | TQB3616 Capsule- After meal + TQB3616 Capsule- Fasted, TQB3616 Capsule- Fasted+ TQB3616 Capsule- After meal |
Primary outcome
Peak concentration(Cmax)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Maximum plasma drug concentration
Area under the time-concentration curve from 0 to t hours after drug administration(AUC0-t))
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Area under the plasma concentration-time curve from the time of first dose to the time of the last measurable concentration
Area under the time-concentration curve from 0 to infinity after drug administration(AUC0-∞)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Area under the plasma concentration-time curve from the time of first dosing extrapolated to infinity
12 secondary outcomes
Time to peak(Tmax)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Elimination half-life(t1/2)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Apparent volume of distribution(Vd/F)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Apparent clearance(CL/F)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Bioavailability(F)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Elimination rate constant (λz)
Time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Body temperature
Time frame: The first and second cycles before adminisyration, 1, 2, 6, 8, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Pulse
Time frame: The first and second cycles before adminisyration, 1, 2, 6, 8, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Blood pressure
Time frame: The first and second cycles before adminisyration, 1, 2, 6, 8, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)
Physical examination
Time frame: After the end of the first cycle and the second cycle (each cycle is 12 days)
Electrocardiogram QT interval
Time frame: After the end of the first cycle and the second cycle (each cycle is 12 days)
Adverse Events
Time frame: Up to 31 days (each cycle is 12 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 40520159Dai J, Zhou Y, Zhang L, Ren Q, Liu Z, Wang Y, Cheng Y, Deng Q, Yang H, Zhang H. The food effect on the pharmacokinetics of TQB3616 capsule in Chinse healthy subjects: a randomized, open-label, single-center, two-period, two-sequence crossover phase I clinical trial. Front Pharmacol. 2025 May 30;16:1586368. doi: 10.3389/fphar.2025.1586368. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB3616 Capsule in people with Recurrent/Metastatic 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 25 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration(Cmax) (time frame: The first and second cycles before administration, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 12, 24, 48, 72, 120, 168 and 264 hours after administration (each cycle is 12 days)). The study lists 3 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 NCT05344729, which also lists 1 linked publication.
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 25 Apr 2022.