Hepatic InsufficiencyPhase 1NCT06620731
Clinical Trial of FCN-437c Capsule in Patients With Hepatic Insufficiency
A Phase 1 study testing FCN-437c capsule in people with Hepatic Insufficiency, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate and compare the safety and efficacy of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- FCN-437c capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2023to 27 Sep 2023
- 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
- Subjects with hepatic impairment must meet all of the following criteria to enter this study.
- Sign the informed consent form before the trial, and fully understand the content, process and possible adverse effects of the trial, and be willing to strictly comply with the requirements of the trial program to complete the study.
- 18 to 75 years of age (both sexes) on the date of signing the informed consent form.
- Males weighing ≥ 50 kg, females weighing ≥ 45 kg, with a body mass index (BMI) in the range of 18 kg/m 2 ~32 kg/m 2 (including threshold values).
- Chronic, stable (no clinically significant change in disease status prior to study drug administration, as determined by the investigator), hepatic impairment due to primary liver disease (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease, etc.), assessed as Grade A/mild (Child-Pugh score: 5-6) or Grade B/moderate (Child-Pugh score: 7-9) prior to study drug administration; in which the investigator uses standardized diagnostic techniques, the investigator uses standard diagnostic techniques, and the investigator uses standardized treatment methods to determine whether the disease is clinically stable or clinically stable. Those who have Grade A/mild (Child-Pugh Score: 5-6) or Grade B/moderate (Child-Pugh Score: 7-9) liver dysfunction; among them, those who are diagnosed with chronic liver dysfunction by the investigator using standardized diagnostic methods, combined with the patient's past medical history, laboratory tests, liver biopsy, or imaging studies, etc. will be evaluated according to the Child-Pugh Score;
- have had a stable regimen of medications for hepatic impairment, complications, and other concomitant conditions for at least 14 days prior to administration of study drug, which does not require adjustment of the medication (including type of medication, dosage, or frequency of medication) (except for subjects with moderate hepatic impairment who require the use of an oral diuretic at any time if ascites is present); or have not been on medication.
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- Vital organ function meets the following criteria.
- Neutrophil count (ANC) ≥1.0 x 10 9 /L (1,000/mm 3 ).
- Platelets ≥ 50.0 x 10 9 /L (50,000/mm 3 ).
- Hemoglobin (Hgb) ≥7.0 g/dL (70 g/L).
- Albuminous aminotransferase (ALT) and albuminous aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN);
- Creatinine clearance (CLcr, calculated using the Cockcroft-Gault formula for creatinine clearance, Annex II) > 60mL/min.
- QTc interval (QTcF) corrected by Fridericia's criteria ≤470 msec in men and ≤480 msec in women.
- The investigator determines the acceptable physical status based on the subject's medical history, physical examination, vital signs, laboratory tests (routine blood, blood biochemistry, urinalysis, coagulation, etc.), and 12-lead electrocardiogram;
- Male and female subjects of childbearing potential are willing to use adequate and effective contraception after signing the informed consent form, during the study, and for 6 months after administration of study medication; women of childbearing potential must have a negative serum pregnancy test within 24 days prior to study drug administration.
- Healthy subjects must meet all of the following criteria to enter this study.
- Sign the informed consent form before the trial, and fully understand the content, process and possible adverse effects of the trial, and be willing to strictly comply with the requirements of the trial program to complete the study.
- On the date of signing the informed consent form, the patients were 18 to 75 years old (including both ends)(required age matching with the liver function impairment group, the average age of the healthy subjects group was within the range of the average age of the mild and moderate liver function impairment group ±10 years), both men and women (required gender matching with the liver function impairment group, the average age of the liver function impairment group was within the range of the liver function impairment group ±10 years). The number of subjects per sex in the healthy group was required to be similar to that in the mild and moderate liver dysfunction groups (±1 subject/sex).
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) within the range of 18 kg/m 2 ~32 kg/m 2 (including the threshold value) (to be weight-matched with the hepatic impairment group, the average weight of the healthy subjects group is within the range of the average weight of the group with mild and moderate hepatic impairment ± 10 kg).
- Normal or abnormal physical examination, vital signs, laboratory tests (blood, blood biochemistry, urine, prothrombin, etc.), 12-lead electrocardiogram, abdominal ultrasound, etc. that are not clinically significant in the judgment of the investigator.
- Male and female subjects of childbearing potential are willing to use adequate and effective contraception after signing the informed consent form, during the study period, and for 6 months after taking the study drug; women of childbearing potential must have had a negative serum pregnancy test within 24 h prior to the administration of study drug.
Who cannot join
- Subjects with hepatic impairment will be excluded from the study if they meet any of the following criteria.
- Subjects with any of the following conditions: drug induced liver injury; history of liver transplantation; cirrhotic patients with liver failure or complications such as grade 3/4 hepatic encephalopathy, ruptured varices of the fundus esophagus, or hemorrhage, which in the opinion of the investigator are inappropriate; severe/advanced peritoneal or pleural effusions requiring puncture drainage and albumin supplementation.
- Diseases affecting the excretion of bile, such as biliary cirrhosis.
- those with severe portal hypertension or previous portosystemic shunts, including transjugular intrahepatic portosystemic shunts.
- In addition to primary diseases of the liver, have previously suffered from serious primary diseases of other important organs, including but not limited to neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, hematological, immunological, etc., which, in the judgment of the investigator, make them unsuitable for participation in this trial.
- Myocardial infarction, severe/unstable colic, symptomatic congestive heart failure (NYHA class II-IV), or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention within 6 months prior to study entry.
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- any other malignancy diagnosed within 5 years prior to study participation, except for radically treated early stage malignancies (carcinoma in situ or stage I tumors), such as adequately treated basal cell or squamous cell skin cancers or carcinoma in situ of the cervix.
- severe infection, trauma, gastrointestinal surgery or other major surgical procedure within 4 weeks prior to screening;
- have lost or donated ≥400 mL of blood or received a red blood cell transfusion within 1 month prior to screening; or have taken any clinical trial medication within 1 month prior to screening.
- allergy, including a history of severe drug allergy or drug metabolism; known hypersensitivity to FCN-437C capsule or its excipients.
- Regular drinkers (≥14 units of alcohol per week: 1 unit = 360 mL of beer, or 45 mL of 40% alcohol by volume, or 150 mL of wine) in the 6 months prior to screening; smokers ≥5 cigarettes per day in the 3 months prior to screening; those with a positive alcohol screen; and those who are unable to abstain from smoking and alcohol for the duration of the trial.
- a history of drug use, or a history of substance abuse within the past 5 years, or a positive drug screen (except for a positive drug screen due to concomitant medication use).
- HIV antibody-positive and syphilis antibody-positive patients; syphilis antibody-positive patients can be enrolled if they are negative for RPR.
- pregnant or breastfeeding women.
- persons who have received a live (attenuated) vaccine (other than influenza vaccine) within 14 days prior to screening or who plan to receive it during the course of the trial.
- who have taken a strong or moderate inducer or strong or moderate inhibitor of CYP3A (Annex III), or prescription, over-the-counter, herbal, or dietary supplements other than medications for the treatment of hepatic impairment and other concomitant diseases within 14 days prior to administration of study drug.
- ingestion of grapefruit or grapefruit-containing products, fruit juices, foods or beverages containing methylxanthines (e.g., tea, coffee, cola, chocolate, functional beverages) or alcohol within 72 hours prior to the administration of the study drug; strenuous physical activity; or any other factor that affects the absorption, distribution, metabolism, excretion, etc. of the drug.
- the presence of other serious physical or mental illnesses or abnormal laboratory tests, and other factors that may increase the risk of participation in the study or interfere with the results of the study; and any other condition that, in the opinion of the investigator, makes participation in this study inappropriate.
- Healthy subjects were not eligible to participate in this study if they met any of the following criteria.
- a previous history of liver impairment, or a physical examination and laboratory tests at the time of screening suggesting the presence or potential presence of liver impairment.
- Previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, immunological, etc., which, in the judgment of the investigator, are not suitable for participation in this trial;
- severe infection, trauma, gastrointestinal surgery or other major surgical procedure within 4 weeks prior to screening;
- have lost or donated ≥400 mL of blood or received a blood transfusion within 3 months prior to screening; or have taken any clinical trial medication.
- allergy, including a history of severe drug allergy or drug metabolism; known hypersensitivity to FCN-437c capsule or its excipients.
- Regular alcohol drinkers in the 6 months prior to screening (≥14 units of alcohol per week: 1 unit=beer 360 mL, or 45 mL of 40% alcohol by volume spirits, or 150 mL of wine); smoked ≥5 cigarettes per day in the 3 months prior to screening; screened positive for alcohol; and were unable to abstain from smoking and alcohol during the trial.
- a history of drug abuse, or a history of substance abuse within the past five years, or a positive drug screen.
- Hepatitis B surface antigen (HBsAg) positive, Hepatitis C (HCV) antibody positive, HIV antibody positive, Syphilis antibody positive.
- QTc intervals (QTcF) corrected by Fridericia's criteria >470 msec in men and >480 msec in women.
- pregnant or breastfeeding women.
- persons who have received a live attenuated vaccine within 14 days prior to screening or who plan to receive a vaccine during the course of the trial (except for influenza vaccine).
- have taken an inducer or inhibitor of CYP3A (Annex III), or any prescription, over-the-counter, herbal, or dietary supplement within 14 days prior to administration of study drug.
- ingestion of grapefruit or grapefruit-containing products, fruit juices, foods or beverages containing methylxanthines (e.g., tea, coffee, cola, chocolate, functional beverages) or alcohol within 72 hours prior to the administration of the study drug; strenuous physical activity; or any other factor that affects the absorption, distribution, metabolism, excretion, etc. of the drug.
- the presence of other serious physical or mental illnesses or abnormal laboratory tests, and other factors that may increase the risk of participation in the study or interfere with the results of the study; and any other condition that, in the opinion of the investigator, makes participation in the study unsuitable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-dose, Parallel, Open-label Pharmacokinetic Study of FCN-437c Capsule in Subjects With Impaired Liver Function
To evaluate and compare the safety and efficacy of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment.
- Conditions
- Hepatic Insufficiency
- Being tested
- FCN-437c capsule
- Keywords
- Clinical Pharmacology, Hepatic insufficiency
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCN-437c capsuleDrug
Take 200 mg of FCN-437c capsules with approximately 240 mL of warm water in the morning on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| mild hepatic impairment group | Experimental | participants with mild hepatic impairment(Child-Pugh A) Receives: Drug: FCN-437c capsule |
| moderate hepatic impairment group | Experimental | participants with moderate hepatic impairment (Child-Pugh B) Receives: Drug: FCN-437c capsule |
| health volunteer group | Experimental | Normal hepatic function Receives: Drug: FCN-437c capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
AUC0-t
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
AUC0-∞
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
Secondary outcomes (6)
Tmax
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
t1/2
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
CL/F
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
Vz/F
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
Fu
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
AUC0-t,u
According to different liver function group measurement
Measured: Within 0.5 hours before administration to 192 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start4 Sep 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
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 Hepatic InsufficiencyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, PI, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620731
- Sponsor's protocol ID
- FCN-437c-CP-005
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Liu J, Ding Y, Yang X, Fu Y, Sun Y. Safety and pharmacokinetics of FCN-437c, a novel cyclin-dependent kinase 4/6 inhibitor, in Chinese patients with hepatic impairment. Invest New Drugs. 2025 Aug;43(4):792-799. doi: 10.1007/s10637-025-01552-5. Epub 2025 Jul 15.
PubMed 40663244
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Parallel, Open-label Pharmacokinetic Study of FCN-437c Capsule in Subjects With Impaired Liver Function
- ClinicalTrials.gov ID
- NCT06620731
- Acronym / sponsor ID
- FCN-437c-CP-005
- Conditions
- Hepatic Insufficiency
- Keywords
- Clinical Pharmacology, Hepatic insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 1 Oct 2024 (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.
To evaluate and compare the safety and efficacy of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild hepatic impairment group | Experimental | Drug: FCN-437c capsuleparticipants with mild hepatic impairment(Child-Pugh A) |
| moderate hepatic impairment group | Experimental | Drug: FCN-437c capsuleparticipants with moderate hepatic impairment (Child-Pugh B) |
| health volunteer group | Experimental | Drug: FCN-437c capsuleNormal hepatic function |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subjects with hepatic impairment must meet all of the following criteria to enter this study.
- Sign the informed consent form before the trial, and fully understand the content, process and possible adverse effects of the trial, and be willing to strictly comply with the requirements of the trial program to complete the study.
- 18 to 75 years of age (both sexes) on the date of signing the informed consent form.
- Males weighing ≥ 50 kg, females weighing ≥ 45 kg, with a body mass index (BMI) in the range of 18 kg/m 2 ~32 kg/m 2 (including threshold values).
- Chronic, stable (no clinically significant change in disease status prior to study drug administration, as determined by the investigator), hepatic impairment due to primary liver disease (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease, etc.), assessed as Grade A/mild (Child-Pugh score: 5-6) or Grade B/moderate (Child-Pugh score: 7-9) prior to study drug administration; in which the investigator uses standardized diagnostic techniques, the investigator uses standard diagnostic techniques, and the investigator uses standardized treatment methods to determine whether the disease is clinically stable or clinically stable. Those who have Grade A/mild (Child-Pugh Score: 5-6) or Grade B/moderate (Child-Pugh Score: 7-9) liver dysfunction; among them, those who are diagnosed with chronic liver dysfunction by the investigator using standardized diagnostic methods, combined with the patient's past medical history, laboratory tests, liver biopsy, or imaging studies, etc. will be evaluated according to the Child-Pugh Score;
Key exclusion criteria (33 listed)
- Subjects with hepatic impairment will be excluded from the study if they meet any of the following criteria.
- Subjects with any of the following conditions: drug induced liver injury; history of liver transplantation; cirrhotic patients with liver failure or complications such as grade 3/4 hepatic encephalopathy, ruptured varices of the fundus esophagus, or hemorrhage, which in the opinion of the investigator are inappropriate; severe/advanced peritoneal or pleural effusions requiring puncture drainage and albumin supplementation.
- Diseases affecting the excretion of bile, such as biliary cirrhosis.
- those with severe portal hypertension or previous portosystemic shunts, including transjugular intrahepatic portosystemic shunts.
- In addition to primary diseases of the liver, have previously suffered from serious primary diseases of other important organs, including but not limited to neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, hematological, immunological, etc., which, in the judgment of the investigator, make them unsuitable for participation in this trial.
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 |
|---|---|---|
| FCN-437c capsuleTake 200 mg of FCN-437c capsules with approximately 240 mL of warm water in the morning on an empty stomach. | Drug | health volunteer group, mild hepatic impairment group, moderate hepatic impairment group |
Primary outcome
Cmax
Time frame: Within 0.5 hours before administration to 192 hours after administration
According to different liver function group measurement
AUC0-t
Time frame: Within 0.5 hours before administration to 192 hours after administration
According to different liver function group measurement
AUC0-∞
Time frame: Within 0.5 hours before administration to 192 hours after administration
According to different liver function group measurement
6 secondary outcomes
Tmax
Time frame: Within 0.5 hours before administration to 192 hours after administration
t1/2
Time frame: Within 0.5 hours before administration to 192 hours after administration
CL/F
Time frame: Within 0.5 hours before administration to 192 hours after administration
Vz/F
Time frame: Within 0.5 hours before administration to 192 hours after administration
Fu
Time frame: Within 0.5 hours before administration to 192 hours after administration
AUC0-t,u
Time frame: Within 0.5 hours before administration to 192 hours after administration
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 12 Nov 2024.
- Derived from this study: PubMed 40663244Xu J, Liu J, Ding Y, Yang X, Fu Y, Sun Y. Safety and pharmacokinetics of FCN-437c, a novel cyclin-dependent kinase 4/6 inhibitor, in Chinese patients with hepatic impairment. Invest New Drugs. 2025 Aug;43(4):792-799. doi: 10.1007/s10637-025-01552-5. Epub 2025 Jul 15.
- Individual participant dataSharing planned: No
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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.
Yanhua Ding, PI principal investigator
The First Hospital of Jilin University
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 FCN-437c capsule in people with Hepatic Insufficiency, run by Ahon Pharmaceutical 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 21 inclusion and 33 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 12 Nov 2024. 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?
Cmax (time frame: Within 0.5 hours before administration to 192 hours after administration). 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 NCT06620731, 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 12 Nov 2024.