Actively Recruiting
Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2026-04-06
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beijing Continent Pharmaceutical Co, Ltd.
Lead Sponsor
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Hydronidone capsules, a new pyridinone-based drug, to understand its safety and how it behaves in the body, especially in patients with kidney problems. Although preliminary studies showed Hydronidone may be safe and effective for liver fibrosis caused by chronic hepatitis B, this trial focuses on how the drug works and is tolerated in people with different levels of kidney function. Participants will take a single 90mg dose of Hydronidone capsules on an empty stomach on the first day. The study includes groups of healthy individuals and patients with mild, moderate, or severe renal insufficiency, defined by their estimated glomerular filtration rate (eGFR). Each participant receives the same dose, and the trial compares these groups to assess differences in drug processing. During the study, researchers will collect blood and urine samples over 48 hours to measure drug and metabolite levels. Safety will be monitored through ultrasound exams of various organs and electrocardiograms within 72 hours after dosing. Participants will be observed for any adverse events, and their overall health will be assessed before and after the study period, which runs until July 2026.
CONDITIONS
Brief Title
A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Chinese adults or patients with renal dysfunction aged 18 to 70 years inclusive
- Healthy subjects with eGFR between 90 and 130 mL/min
- Patients with mild renal dysfunction (eGFR 60-89 mL/min), moderate (30-59 mL/min), or severe (15-29 mL/min)
- Male participants weighing at least 50 kg, female participants at least 45 kg
- Body mass index between 18 and 28
- Agreement to avoid smoking, alcohol, fruit juices, caffeine, and tea from 24 hours before to the end of the trial
- Ability to understand and sign informed consent and comply with study requirements
You will not qualify if you...
- Participation in another clinical trial within 3 months prior to this study
- Any disease affecting safety or drug processing besides renal insufficiency for patients
- Any disease affecting safety or drug processing for healthy subjects, including heart, liver, kidney, endocrine, digestive, immune, or respiratory diseases
- Allergy to two or more drugs, food, or lactose intolerance
- Use of drugs affecting liver metabolism within 28 days before dosing
- Use of drugs affecting SULT and UGT enzymes within 7 days before dosing, if not stopped
- Intolerance to venipuncture or history of fainting from needles
- Excessive long-term caffeine consumption or recent intake of substances affecting liver enzymes
- Blood donation or significant bleeding within 3 months prior to dosing or planned during the study
- Acute diseases during screening or before dosing
- Pregnancy, breastfeeding, or plans for pregnancy without agreed contraception during the study
- Surgery within 3 months before screening or planned during the study affecting drug processing
- History of drug use or abuse
- Smoking more than 5 cigarettes per day within 14 days before screening or inability to stop tobacco use
- Abnormal physical exam, ECG, or lab test results with clinical significance (excluding effects of renal insufficiency)
- Positive tests for nicotine, alcohol, drugs, hepatitis B or C, syphilis, or HIV
- Any condition affecting ability to give informed consent or comply with the trial protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants take a single 90mg dose of hydronidone capsules orally on an empty stomach on Day 1.
1 baseline visit and multiple assessments up to 72 hours after dosing
Duration - Up to 3 days after dosing
Participants are monitored for safety and drug levels through blood and urine tests and ultrasound and ECG examinations following treatment.
Approximately 3 follow-up visits within 72 hours after dosing
Trial Site Locations
Total: 1 location
1
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, China
Actively Recruiting
Research Team
L
Ling Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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