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Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

A Phase I Pharmacokinetic Study of Hydronidone Capsules in Patients With Varying Degrees of Hepatic Impairment and Normal Hepatic Function.

NCT07394309•Beijing Continent Pharmaceutical Co, Ltd.

View on ClinicalTrials.gov

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%).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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).

Exclusion Criteria

•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.
•12-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.
+27 more criteria

Locations (1)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Key Dates

Start Date

February 15, 2026

Primary Completion Date

February 15, 2026

Completion Date

October 30, 2026

Last Updated

February 12, 2026

Enrollment

ESTIMATED participants

Conditions

Liver Fibrosis

Interventions

Hydronidone capsules

DRUG

Contacts

Zhang Ling, Dr

CONTACT

+86-13501209210 zhangling@bjcontinent.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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