Renal Impairment
Conditions
Brief summary
This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.
Interventions
DRUGVC005 Tablets
Oral single dose
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements; 2. Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs; 3. Male and female participants aged 18 to 70 years (inclusive); 4. Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg/m² (inclusive).
Exclusion criteria
1. History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components; 2. History of drug abuse, drug addiction and/or alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening; 3. Blood donation or significant blood loss (\> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial; 4. Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial; 5. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex; 6. Known active bacterial, viral, fungal, parasitic infection or other infection, or any infectious event requiring antibiotic treatment or hospitalization (within 4 weeks prior to screening), or any acute infection within 2 weeks of baseline; 7. History of dysphagia or, within 6 months prior to screening, any gastrointestinal conditions affecting drug absorption or excretion (e.g., reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), history of liver disease (regardless of cure), and history of surgery (e.g., gastrointestinal surgery and other major surgeries).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve(AUC） | Day1-Day3 |
| Maximum Observed Plasma Concentration (Cmax) | Day1-Day3 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHuan Zhou
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed