Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls

NCT07394309 | Not Yet Recruiting Phase 1

• 1 other identifier: KDN-F351-202507
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. The administration method is a single oral dose of 90 mg hydroxynidone capsules under fasting conditions. Participants meeting the inclusion criteria with corresponding degrees of hepatic impairment and those with normal hepatic function will be enrolled. Each group will complete the study with 10 participants. Matched participants will be comparable in terms of sex (±1 participant per sex), mean age (±10 years), and mean BMI (±10%).

Conditions

Liver Fibrosis

Keywords

Hydronidone; Liver Fibrosis; Patients with hepatic fibrosis due to chronic hepatitis B

Outcome Measures

Primary Outcomes (13)

• Pharmacokinetic Parameter of Hydronidone: Cmax

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone: AUC0-t

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:AUC0-∞

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:Tmax

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:t1/2

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:λz

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:CL/F

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:MRT

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:Vz/F

  Within 48 hours of administration

• Pharmacokinetic Parameter of Hydronidone:Ratio of free drugsRatio of free drugs

  Within 48 hours of administration

• Difference in the main parameters AUC₀-t between patients with hepatic impairment and participants with normal hepatic function.

  Within 48 hours of administration

• Difference in the main parameters AUC₀-∞ between patients with hepatic impairment and participants with normal hepatic function.

  Within 48 hours of administration

• Difference in the main parameters Cmax between patients with hepatic impairment and participants with normal hepatic function.

  Within 48 hours of administration

Secondary Outcomes (6)

• Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: Cmax (Metabolic Ratio).

  Within 48 hours after administration

• Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-t, (Metabolic Ratio).

  Within 48 hours after administration

• Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: MR (Metabolic Ratio).

  Within 48 hours after administration

• Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-∞, (Metabolic Ratio).

  Within 48 hours after administration

• Plasma Pharmacokinetic Parameters of Metabolites M3 andM4:Tmax(Metabolic Ratio).

  Within 48 hours after administration

Study Arms (3)

Group One A(mild hepatic impairment group)

EXPERIMENTAL

10 participants with mild hepatic impairment (Child-Pugh A, score 5-6).

Drug: Hydronidone capsules

Group Two B(moderate hepatic impairment group)

EXPERIMENTAL

10 participants with moderate hepatic impairment (Child-Pugh Class B, score of 7-9).

Drug: Hydronidone capsules

Group Three C（control group, normal hepatic function group）

EXPERIMENTAL

Matched 10 healthy participants with normal hepatic function will serve as the control group.

Drug: Hydronidone capsules

Interventions

Hydronidone capsules DRUG

A single oral dose of 90 mg of the investigational drug (3 Hydronidone capsules) under fasting conditions, administered with 240 mL of water.

Group One A(mild hepatic impairment group); Group Three C（control group, normal hepatic function group）; Group Two B(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:

• Participants must meet all of the following criteria to be eligible for enrollment:
• Participants fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process as required by the protocol.
• Age between 18 and 75 years (inclusive), both males and females.
• At screening, male participants weigh ≥50 kg, female participants weigh ≥45 kg, and body mass index \[BMI = weight (kg) / height² (m²)\] is within the range of 18 to 32 kg/m² (inclusive).
• Participants and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent form until 6 months after the last dose of the investigational drug, and voluntarily agree to use effective contraceptive measures.
• Participants with hepatic impairment due to pre-existing primary liver disease, classified as Child-Pugh Class A (score of 5-6) or Class B (score of 7-9) at screening. They must not have received albumin infusion within 14 days prior to screening and must have a confirmed diagnosis of stable (≥1 month) hepatic impairment based on medical history, physical examination, laboratory tests, or imaging studies.
• Participants have not taken any medication within 1 week prior to screening, or for those requiring long-term treatment for hepatic impairment and/or other comorbidities, their medication regimen must have been stable for at least 4 weeks (stability is judged by the investigator, excluding medications prohibited by the protocol).

You may not qualify if:

• Known history of allergy to any component of the investigational product, drugs of the same class (GLP-1 receptor agonists), or their excipients; or history of allergic constitution (multiple drug and food allergies); or history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.).
• Diagnosis of malignant tumor, or history of malignant tumor within 5 years prior to screening (except for: prior hepatocellular carcinoma surgery with stability ≥2 years; treated non-melanoma skin cancer with no signs of recurrence; and excised cervical intraepithelial neoplasia).
• Presence of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening.
• lead electrocardiogram (ECG) abnormalities considered clinically significant by the investigator \[e.g., tachycardia/bradycardia requiring medication, II-III degree atrioventricular block, prolonged QTcF interval (male QTcF \>470 ms, female QTcF \>480 ms, corrected using Fridericia's formula), or other abnormalities deemed clinically significant by the physician\].
• Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula \<60 mL/min/1.73 m².
• Planned surgical procedure or hospitalization tendency during the trial period.
• Positive for HIV antibody (HIV-Ab) or Treponema pallidum (TP) antibody.
• Use of inducers or inhibitors of drug-metabolizing enzymes (CYP3A4 inducers and inhibitors, detailed list in Appendix 4: Common Drugs that are Inhibitors or Inducers of Drug-Metabolizing Enzymes) within 4 weeks prior to dosing.
• Use of drugs known to inhibit or induce SULT and UGT enzymes within 7 days prior to investigational drug administration, and inability to discontinue such use.
• Use of any medication (including herbal medicines, vitamins, health supplements) within 14 days (or 5 half-lives, whichever is longer) prior to dosing, except for stable medications in participants with hepatic impairment.
• Participation in another clinical trial and receipt of an investigational drug or medical device within 1 month prior to screening, with the last dose date of the previous clinical study as the reference point (if the previous investigational drug has a long half-life, at least 5 half-lives must elapse before dosing in this study).
• History of blood loss or blood donation ≥400 mL within 3 months prior to dosing, or plans to donate blood within 1 month after the end of this trial.
• History of smoking or smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from any tobacco products during the study, or positive nicotine test at baseline.
• Regular alcohol consumption at present or within 1 month prior to screening, defined as females consuming more than 7 units of alcohol per week or males consuming more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits with 40% alcohol, or 100 mL of wine); or positive alcohol breath test at baseline, or inability to abstain from alcohol during the trial.
• History of drug abuse, or use of soft drugs (e.g., marijuana) within 3 months prior to dosing, or use of hard drugs (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year prior to dosing, or positive drug abuse screening at baseline.

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

hydronidone

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhang Ling, Dr

CONTACT

+86-13501209210; zhangling@bjcontinent.com

Study Design

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

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: February 15, 2026
• Primary Completion: February 15, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CN (1)