A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Ins… (NCT05208814) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects
China16 participantsStarted 2022-03-31
Plain-language summary
To evaluate the effect of renal insufficiency on the pharmacokinetics of TPN171H tablets after single dose oral administration, so as to provide basis for formulating clinical medication plan for patients with renal insufficiency; To evaluate the safety of TPN171H tablets in patients with renal insufficiency and healthy subjects
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Healthy subjects meet: GFR ≥ 90ml / min and \< 130ml / min; the GFR of the subjects in the corresponding group meet the criteria of MDRD in the stage of renal function. Mild renal insufficiency (CKD 2 stage) : GFR : 60-89 mL/min; moderate renal insufficiency (CKD 3 stage) : GFR : 30-59mL/min; Severe renal insufficiency (CKD 4): GFR: 15-29 mL/min; renal failure (CKD 5) : GFR\<15 mL/min；
✓. Be able to understand the procedures and methods of this study, be willing to strictly abide by the clinical trial scheme, complete this trial, and voluntarily sign the informed consent.
Exclusion criteria
✕. Dysphagia;
✕. Arrhythmia with clinical significance, or QTCF \> 450ms (male) and QTCF \> 470ms (female);
✕. Subjects with acute hepatitis, chronic liver disease, positive treponema pallidum antibody, positive HBV surface antigen, positive HCV antibody and positive HIV antibody; Or either ALT or AST is greater than 2 times the upper limit of the normal value, and the total bilirubin is greater than 1.5 times the upper limit of the normal value.
✕. Subjects with history of drug allergy, allergic constitution and family history of allergy;
✕. Subjects who have used drugs that affect the function of liver metabolic enzymes within 30 days before the start of the test, or those who need to use other drugs that may affect the absorption, distribution, metabolism and excretion of the tested drugs during the test;
What they're measuring
1
Area under the curve (AUC)
Timeframe: 72 hours or 120 hours after dosing
2
Time to maximum plasma concentration (Tmax)
Timeframe: 72 hours or 120 hours after dosing
3
Maximum plasma concentration (Cmax)
Timeframe: 72 hours or 120 hours after dosing
4
Terminal half-life (t 1/2)
Timeframe: 72 hours or 120 hours
5
Apparent distribution volume (Vd)
Timeframe: 72 hours or 120 hours after dosing
6
Clearance rate (CL)
Timeframe: 72 hours or 120 hours after dosing
7
Oral bioavailability (F)
Timeframe: 72 hours or 120 hours after dosing
8
Adverse events
Timeframe: From administration of study drug through 8 days after administration of study drug
✕. Subjects who drink too much (more than 8 cups a day, 1 cup = 250mL) of tea, coffee or caffeinated beverages within 6 months before screening; or those who consumed any food or beverage rich in caffeine and / or xanthine within 48 hours before the first administration of the study to the end of the test.
✕. Subjects who have a history of alcohol, tobacco and drug abuse; subjects whose alcohol breath test is positive, and urine drugs (morphine, tetrahydrocannabinol acid, methamphetamine, dimethylbisoxyamphetamine, ketamine) screening results are positive;
✕. Subjects who participated in the drug clinical trial within 3 months before the trial;