None listed
Conditions
Interventions
Mild or severe renal impairment group:LNK01001 24mg
Moderate renal impairment group:LNK01001 24mg
healthy subject group:LNK01001 24mg
Sponsors
37 Guoxue Lane, Chengdu, Sichuan
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: To be eligible for this study, subjects must meet all the following eligibility criteria: 1. voluntarily sign the ICF before any of trial related activities, understand the study procedures and methods, and willing to strictly follow the clinical trial protocol to complete this trial 2. the subjects (including partners) are willing to use the protocol specified contraceptive methods, have no plan to conceive, donate sperms or eggs since screening until 30 days after study treatment 3.Male or female aged 18 to 70 years old, both inclusive, when signing the ICF. 4. At least 50 kg for men or 45 kg for women;BMI is within the range of 18.0~32.0 kg/m2, both inclusive. Additional inclusion criteria for healthy subjects: 5. No clinically significant abnormalities identified by medical history and/or examinations at the Screening Visit. 6. The estimated glomerular filtration rate (eGFR) calculated by the MDRD formula is =90 mL/min and <130 mL/min. Additional inclusion criteria for subjects with renal impairment: 7. The estimated glomerular filtration rate (eGFR) calculated by the MDRD formula of the subjects met the renal function staging criteria of the corresponding groups ?Mild renal impairment group:60= eGFR=89 mL/min ?Moderate renal impairment group:30= eGFR=59 mL/min ?Severe renal impairment group:15= eGFR=29 mL/min 8.Must have diagnosis of stable renal impairment for 3 months at baseline, and who are receiving concomitant medications should be on a stable drug regimen for at least 2 weeks prior to study drug administration.
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study if any of the following criteria apply: 1.History of significant drug sensitivity or drug allergy, or known hypersensitivity to the study drugs or to any ingredients. 2. During screening, ECG shows abnormal QTcF (male > 470 msec, female > 480 msec, corrected by Fridericia's method); if abnormal (male QTcF > 470 msec, female QTcF > 480 msec), measure 3 times and use the average to determine eligibility 3.History of dysphagia or any gastrointestinal disorder that interferes with drug absorption, including a history of frequent nausea or vomiting of any etiology. 4. history of disseminated herpes zoster, disseminated herpes simplex, or recurrent local skin herpes zoster 5.Have untreated or inadequately treated active or latent infection with Mycobacterium tuberculosis(TB) infections. Positive ? interferon release test or chest X-ray indicates active TB infection 6. Any history of chronic infection, any history of recurrent infection, any history of latent infection, or any acute infection within 2 weeks of baseline 7.Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. 8. Subjects with routine dialysis or have history of kidney transplantation, hepatorenal syndrome, or acute kidney injury 9.Have severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks preceding the Screening Visit. 10.Vaccination within 2 weeks preceding the Screening Visit or plan to have vaccination during study or within 1 month after study drug administration. 11.Donate blood or lost of blood =400 mL within 3 month before screening, or plan to donate blood during the study. 12.Treatment contain strong/moderate inhibitors or inducers involving cytochrome P450 2C9 enzyme or p-glycoprotein (p-gp) within 1 month (or within 5 half-lives of the drug, whichever is longer) prior to study drug administration. 13.Use any prescription drugs, over-the-counter drugs, herbal medicines or supplements within 7 days prior to study drug administration or within 5 half-lives of the drug (whichever is longer). For subjects with renal impairment, the concomitant use of necessary concomitant therapeutic drugs that do not interfere with the PK of the study drug is permitted. 14.Take special diets and/or drank excessive amounts of tea, coffee, grapefruit/grapefruit juice and/or caffeinated drinks within 24 hours prior to study drug administration. 15.Alcoholics within 3 months preceding the Screening Visit or alcohol detection positive; average daily smoking =10 cigarettes within 3 months preceding the Screening Visit. 16.History of drug abuse or drug abuse detection positive. 17.Any indicator of hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, human immunodeficiency virus (HIV) antigen/antibody or syphilis antibody detection positive. 18.Be a pregnant or lactating female, or have a positive pregnancy test. 19.Unable to tolerate venipuncture or allergic to heparin. 20.Treatment with other investigational drug(s) within 3 months preceding the Screening Visit. 21.Any other factors that, as determined by the investigator, are not suitable for the study. Additional exclusion criteria for healthy subjects: 22.With circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, mental disease, met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,AUC0-last,AUC0-inf; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax,t1/2,CL/F,Vz/F,Ae,Fe,CLr; | — |
Countries
China
Contacts
Public ContactPing Feng
West China Hospital, Sichuan University
Outcome results
None listed