Lung CancerPhase 1NCT07538973
A Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function
A Phase 1 study testing Anecatibin Fumarate Capsules in people with Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
Trial summary
Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Anecatibin Fumarate Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- Apr 2026to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must meet all of the following inclusion criteria:
- Provide signed informed consent prior to trial participation and have a full understanding of the trial content, procedures, and potential adverse reactions;
- Be male or female subjects aged 18 to 65 years (inclusive);
- Weigh at least 50 kg for males and at least 45 kg for females. Body Mass Index (BMI = weight (kg) / height² (m²)) within the range of 18 to 30 kg/m² (inclusive of boundary values);
- Subjects and their partners agree to voluntarily adopt effective contraceptive measures from screening until 6 months after the last dose;
- Subjects are able to communicate well with the investigators and can complete the study according to the study protocol.
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- Subjects with normal liver function must also meet the following inclusion criteria:
- Negative test results for Hepatitis B surface antigen and Hepatitis C antibody;
- Normal liver function test results or abnormal results without clinical significance;
- Matched with the hepatic impairment group in terms of male-to-female ratio (±1 subject per gender), mean age (±10 years), and mean body weight (±10 kg).
- Subjects with hepatic impairment must meet the following inclusion criteria:
- Have a history of or be diagnosed at screening with primary liver disease, including but not limited to: Hepatitis B, Hepatitis C, non-alcoholic fatty liver disease, alcoholic liver disease, etc.;
- Hepatic impairment is caused by a previous primary liver disease (diagnosed at least 2 weeks prior to screening; excluding oncology patients) and is classified as Child-Pugh Class A or B;
- Liver function is stable within 2 weeks prior to taking the study drug, as determined by the investigator;
- No medication for liver disease within 4 weeks prior to screening, or on a stable medication regimen for existing underlying conditions.
Who cannot join
- All subjects who meet any of the following exclusion criteria are not eligible for enrollment:
- Suffering from primary diseases of major organs, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, immune, psychiatric, or cardiovascular diseases, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
- Physical examination, vital signs, or clinical laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function) show abnormalities of clinical significance, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
- Participated in any drug clinical trial and used any investigational drug within 3 months prior to screening;
- Tested positive for HIV or syphilis screening;
- Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the study drug (e.g., inability to swallow) or who have undergone gastrointestinal resection that may affect drug absorption, distribution, metabolism, or excretion;
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- Electrocardiogram (ECG) abnormalities of clinical significance (e.g., tachycardia/bradycardia requiring medication, second- or third-degree atrioventricular block, or other abnormalities deemed clinically significant and unsuitable for participation by the Investigator);
- Used any CYP3A4 inhibitors (e.g., macrolide antibiotics such as clarithromycin, triazole antifungals such as itraconazole, and HIV protease inhibitors such as lopinavir) or CYP3A4 inducers (e.g., rifampicin, carbamazepine, and phenytoin) within 4 weeks prior to screening;
- Used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements (e.g., vitamins, calcium supplements) within 2 weeks prior to screening, except for medications used by hepatic impairment patients to treat hepatic impairment and its complications;
- Known allergy to any component of TQ-B3101 capsules, or having an allergic constitution (including a history of drug allergy, prone to rashes, eczema, urticaria, asthma, etc.);
- Smoked an average of more than 5 cigarettes per day within 3 months prior to screening;
- Has a history of drug abuse within 3 months prior to screening, or tested positive for urine drug screening;
- Alcoholic liver disease patients have a history of alcoholism within 12 months prior to screening; other subjects have a history of alcoholism within 3 months prior to screening (average daily alcohol consumption > 2 units [1 unit = 360 mL beer or 45 mL 40% spirits or 150 mL wine]);
- Donated blood or plasma, lost ≥ 200 mL of blood, or undergone plasmapheresis within 4 weeks prior to screening;
- Consumed any food or beverage containing alcohol (or tested positive for alcohol breath test 1 day before dosing; alcoholic liver disease subjects consumed any alcohol-containing substances 2 weeks before dosing), grapefruit juice/pomelo juice, coffee, tea, cola, or chocolate within 1 week before dosing;
- Creatinine clearance (CLcr) < 60 mL/min (calculated by the Cockcroft-Gault formula);
- Female subjects who are lactating or test positive for pregnancy during screening or the trial period;
- Deemed by the Investigator to have any factors making them unsuitable for participation in this trial.
- Subjects with hepatic impairment must also meet the following additional exclusion criteria:
- History of liver transplantation;
- Experienced hepatic encephalopathy within 30 days prior to screening;
- Used any medication that may cause acute hepatotoxicity (e.g., halothane and methotrexate) within 3 months prior to screening;
- Suffered from drug- or virus-induced acute hepatitis within 2 months prior to screening;
- Experienced a rapid deterioration or Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) elevation > 3 times the upper limit of normal within 2 weeks prior to dosing, as judged by the Investigator;
- Experienced worsening of hepatic encephalopathy within 30 days prior to dosing;
- Suffering from diseases affecting bile excretion, such as biliary cirrhosis, hepatic/biliary obstruction, or cholestatic liver disease;
- Patients with liver failure or complications deemed unsuitable by the Investigator, such as hepatic encephalopathy, hepatocellular carcinoma, esophageal-gastric variceal bleeding within 3 months, severe portal hypertension, or history of portosystemic shunt surgery;
- As judged by the Investigator, having concomitant medications that may potentially affect the evaluation of the pharmacokinetic characteristics of TQ-B3101 and its metabolites.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
Yu Cao, Doctor, 18661809090, Caoyu1767@126.com
Xiamen Traditional Chinese Medicine Hospital
Xiamen, Fujian, 361000
Huiqing Liang, Doctor, 13306051108, 13306051108@126.com
Xiaohui Li, Doctor, 13950188576, 467008682@qq.com
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, 450015
Shuang Li, Doctor, 13938529645, li36918@163.com
About this study
Official title: Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function
Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function
- Conditions
- Lung Cancer
- Being tested
- Anecatibin Fumarate Capsules
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecatibin Fumarate CapsulesDrug
Anecatibin fumarate capsule is a prodrug that can be rapidly hydrolyzed into crizotinib in vivo to exert pharmacodynamic effects. Crizotinib is a tyrosine kinase receptor inhibitor, including Anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor Hepatocyte Growth Factor Receptor(HGFR, c-Met), ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1, c-cos), and Recepteur d'Origine Nantais (RON).
| Study group | Role | What they receive |
|---|---|---|
| Anecatibin Fumarate Capsules (TQ-B3101 Capsules) | Experimental | The dose is 300 mg, administered once. Receives: Drug: Anecatibin Fumarate Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Cmax
To determine the Cmax of TQ-B3101 and its benzyloxypyridine metabolites.
Measured: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
To determine the Area Under the Curve (AUC) 0-t
To determine the AUC 0-t of TQ-B3101 and its benzyloxypyridine metabolites.
Measured: The period extends from the date of the first dose to the completion of the end of treatment (EOT) visit, totaling 5 days
To determine the AUC 0-∞
To determine the AUC 0-∞ of TQ-B3101 and its benzyloxypyridine metabolites.
Measured: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Secondary outcomes (5)
Tmax of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the Tmax of TQ-B3101 and its benzyloxy pyridine metabolite.
Measured: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite.
Measured: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite
Measured: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Apparent Clearance (CLz/F) of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the CLz/F of TQ-B3101 and its benzyloxy pyridine metabolite.
Measured: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Numbers of subjects with adverse events
Numbers of subjects with adverse events, including adverse events, clinical symptoms, physical examinations, vital signs (blood pressure, pulse, and body temperature), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), and 12-lead electrocardiogram (ECG).
Measured: The period extends from the first dose date to the completion of the safety follow-up, not to exceed 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT07538973
- Sponsor's protocol ID
- TQ-B3101-I-05
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function
- ClinicalTrials.gov ID
- NCT07538973
- Acronym / sponsor ID
- TQ-B3101-I-05
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anecatibin Fumarate Capsules (TQ-B3101 Capsules) | Experimental | Drug: Anecatibin Fumarate CapsulesThe dose is 300 mg, administered once. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provide signed informed consent prior to trial participation and have a full understanding of the trial content, procedures, and potential adverse reactions;
- Be male or female subjects aged 18 to 65 years (inclusive);
- Weigh at least 50 kg for males and at least 45 kg for females. Body Mass Index (BMI = weight (kg) / height² (m²)) within the range of 18 to 30 kg/m² (inclusive of boundary values);
- Subjects and their partners agree to voluntarily adopt effective contraceptive measures from screening until 6 months after the last dose;
- Subjects are able to communicate well with the investigators and can complete the study according to the study protocol.
Key exclusion criteria (28 listed)
- All subjects who meet any of the following exclusion criteria are not eligible for enrollment:
- Suffering from primary diseases of major organs, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, immune, psychiatric, or cardiovascular diseases, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
- Physical examination, vital signs, or clinical laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function) show abnormalities of clinical significance, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
- Participated in any drug clinical trial and used any investigational drug within 3 months prior to screening;
- Tested positive for HIV or syphilis screening;
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 |
|---|---|---|
| Anecatibin Fumarate CapsulesAnecatibin fumarate capsule is a prodrug that can be rapidly hydrolyzed into crizotinib in vivo to exert pharmacodynamic effects. Crizotinib is a tyrosine kinase receptor inhibitor, including Anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor Hepatocyte Growth Factor Receptor(HGFR, c-Met), ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1, c-cos), and Recepteur d'Origine Nantais (RON). | Drug | Anecatibin Fumarate Capsules (TQ-B3101 Capsules) |
Primary outcome
To determine the Cmax
Time frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
To determine the Cmax of TQ-B3101 and its benzyloxypyridine metabolites.
To determine the Area Under the Curve (AUC) 0-t
Time frame: The period extends from the date of the first dose to the completion of the end of treatment (EOT) visit, totaling 5 days
To determine the AUC 0-t of TQ-B3101 and its benzyloxypyridine metabolites.
To determine the AUC 0-∞
Time frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
To determine the AUC 0-∞ of TQ-B3101 and its benzyloxypyridine metabolites.
5 secondary outcomes
Tmax of TQ-B3101 and its benzyloxy pyridine metabolite
Time frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite
Time frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite
Time frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Apparent Clearance (CLz/F) of TQ-B3101 and its benzyloxy pyridine metabolite
Time frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
Numbers of subjects with adverse events
Time frame: The period extends from the first dose date to the completion of the safety follow-up, not to exceed 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anecatibin Fumarate Capsules in people with Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites 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 15 inclusion and 28 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, Doctor (18661809090, Caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Cmax (time frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 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?
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 20 Apr 2026.