Clinical Trial of FCN-437c Capsule in Patients With Hepatic Insufficiency

NCT06620731 | Completed Phase 1

• 1 other identifier: FCN-437c-CP-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Insufficiency

Keywords

Clinical Pharmacology; Hepatic insufficiency

Outcome Measures

Primary Outcomes (3)

• Cmax

  According to different liver function group measurement

  Within 0.5 hours before administration to 192 hours after administration

• AUC0-t

  According to different liver function group measurement

  Within 0.5 hours before administration to 192 hours after administration

• AUC0-∞

  According to different liver function group measurement

  Within 0.5 hours before administration to 192 hours after administration

Secondary Outcomes (6)

• Tmax

  Within 0.5 hours before administration to 192 hours after administration

• t1/2

  Within 0.5 hours before administration to 192 hours after administration

• CL/F

  Within 0.5 hours before administration to 192 hours after administration

• Vz/F

  Within 0.5 hours before administration to 192 hours after administration

• Fu

  Within 0.5 hours before administration to 192 hours after administration

Study Arms (3)

mild hepatic impairment group

EXPERIMENTAL

participants with mild hepatic impairment(Child-Pugh A)

Drug: FCN-437c capsule

moderate hepatic impairment group

EXPERIMENTAL

participants with moderate hepatic impairment (Child-Pugh B)

Drug: FCN-437c capsule

health volunteer group

EXPERIMENTAL

Normal hepatic function

Drug: FCN-437c capsule

Interventions

FCN-437c capsule DRUG

Take 200 mg of FCN-437c capsules with approximately 240 mL of warm water in the morning on an empty stomach.

health volunteer group; mild hepatic impairment group; moderate hepatic impairment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ahon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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.

  PMID: 40663244 DERIVED

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

FCN-437c

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Yanhua Ding, PI

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: September 4, 2023
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)