Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir (NCT05731804) | Clinical Trial Compass
UnknownPhase 1
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir
China72 participantsStarted 2023-03-01
Plain-language summary
This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. It is divided into Part A (subjects with mild/moderate renal impairment and subjects with normal renal function) and Part B (subjects with moderate hepatic impairment and subjects with normal hepatic function).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
✓. Male and female subjects aged ≥18 years and ≤75 years old.
✓. Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 18 and ≤ 28 kg/m\^2.
✓. The results of screening and baseline blood pregnancy examination of women of childbearing potential are negative, and they are willing to take effective contraceptive measures during the trial and within 3 months after the last administration of the investigational product, or have postmenopause or surgical sterilization; male subjects have no fertility plan during the trial and within 3 months after the last administration of the investigational product and voluntarily take effective contraceptive measures or have surgical sterilization.
✓. The renal function status is stable, and the GFR results of the two tests before administration (at least 3 days interval ) must be in the same CKD stage.
✓. No medication within 14 days before enrollment, or with a stable medication regimen for the treatment of renal impairment or other comorbidities (the type, dose or frequency of medication has not been adjusted for at least 2 weeks).
What they're measuring
1
Cmax of SIM0417 in Part A
Timeframe: Up to 48 hours from SIM0417 administration
2
AUC0-t of SIM0417 in Part A
Timeframe: Up to 48 hours from SIM0417 administration
3
AUC0-∞ of SIM0417 in Part A
Timeframe: Up to 48 hours from SIM0417 administration
4
Cmax of SIM0417 in Part B
Timeframe: Up to 48 hours from SIM0417 administration
5
AUC0-t of SIM0417 in Part B
Timeframe: Up to 48 hours from SIM0417 administration
6
AUC0-∞ of SIM0417 in Part B
Timeframe: Up to 48 hours from SIM0417 administration
✕. Those with allergies, including a history of severe drug allergy or drug allergy; or may be allergic to the study drug or any excipients of the study drug.
✕. Difficulties in venous blood collection.
✕. With severe infection, trauma, major surgical operation, digestive system surgery, and affecting drug absorption within 4 weeks before screening.
✕. Within six months before screening, patients with myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure ( NYHA II-IV ), or history of supraventricular or ventricular arrhythmia or left ventricular impairment which was Clinically significant and requiring treatment or intervention.
✕. Participated in clinical trials of any drug intervention within 3 months before screening.
✕. Blood donation ≥ 400 mL within 3 months before screening, or received blood transfusion or blood products within 1 month before the screening.
✕. Those who are addicted to smoking or drinking within 3 months before screening, and who cannot stop smoking and drinking during the test, or those who have a positive breath test for alcohol. (Remarks: addicted to Smoking is defined as ≥5 cigarettes/day; alcoholism is defined as daily drinking exceeding the following standard amounts: 570 mL of beer, 750 mL of light beer, 200 mL of red wine or 60 mL of white wine, each containing about 20 g of alcohol ).