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This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1: participants with severe renal impairment | Experimental | 8 participants with severe renal impairment will be given 400mg of Leritrelvir |
|
| Experimental 2: healthy participants | Experimental | 8 participants with normal renal function will be given 400mg of Leritrelvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leritrelvir | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | The Cmax of a single dose of Leritrelvir in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared. | 0~96 hours |
| Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast) | The AUClast of a single dose of Leritrelvir in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared. | 0~96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with drug-related adverse events as assessed by CTCAE v5.0 | Day 1 to Day12 |
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Inclusion Criteria:
Body mass index (BMI) ≥19 to ≤28kg/m2 and total body weight >50 kg(male) or >40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
Ability to understand and willingness to sign a written informed consent form;
Participants with normal renal function only:
Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
Glomerular filtration rate (GFR)≥ 90 mL/min
Age, BMI, and sex comparable to those of subjects of severe renal impairment
Participants with severe renal impairment only:
Diagnosis of CKD at least 3 months
glomerular filtration rate (GFR)< 60 mL/min/1.73 m2
Exclusion Criteria:
Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.
Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
Participants with severe renal impairment only:
Participants with acute renal failure, or a kidney transplant history; Or requiring renal dialysis during the study period;
Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm)
New York heart association (NYHA) class III or IV congestive heart failure
Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin > 1.5×ULN;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |