Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects W… (NCT07033182) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects With Renal Impairment and Normal Renal Impairment
China24 participantsStarted 2023-10-30
Plain-language summary
To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for injection in subjects with moderate and severe renal impairment and healthy subjects.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
✓. Male or female subjects aged 18-75 years (inclusive).
✓. Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 \~ 30.0 kg/m2 (inclusive).
✓. Subjects with diagnosis of chronic kidney disease and/or absolute eGFR did not change significantly within 1 month before screening, absolute eGFR met the renal function classification criteria in the corresponding group at screening, severe renal insufficiency, absolute eGFR: 15 \~ 29 mL/min; moderate renal insufficiency, absolute eGFR: 30 \~ 59 mL/min.
✓. Subjects of childbearing potential (including partners), voluntarily take appropriate contraceptive measures from 2 weeks before screening to 3 months after dosing.
✓. Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
✓. Male and female subjects aged 18 - 75 years (inclusive) were matched with subjects in groups A and B for age (mean ± 10 years) and gender (mean ± 1 case of gender in groups A and B).
✓. Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 \~ 30.0 kg/m2, matched with BMI of subjects in groups A and B(mean ± 15%).
Exclusion criteria
✕. Subjects who are known to be allergic to levornidazole phosphate disodium, levornidazole, ornidazole, other nitroimidazoles or their excipients, or have a history of drug or food allergy, or have a history of specific allergic diseases (such as asthma, urticaria, eczema, etc.).
What they're measuring
1
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazole
Timeframe: From Day 1 to Day 5
2
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of levornidazole
Timeframe: From Day 1 to Day 5
3
Maximum Observed Plasma Concentration (Cmax) of levornidazole
Timeframe: From Day 1 to Day 5
4
Clearance (CL) of levornidazole
Timeframe: From Day 1 to Day 5
5
The Volume of Distribution (Vd) of levornidazole
Timeframe: From Day 1 to Day 5
6
Time of Maximum Observed Plasma Concentration (Tmax) of levornidazole
Timeframe: From Day 1 to Day 5
7
Apparent Terminal Elimination Half-life (t1/2) of levornidazole
Timeframe: From Day 1 to Day 5
8
Mean Residence Time (MRT0-t) of levornidazole
Trial details
NCT IDNCT07033182
SponsorYangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
✕. Subjects who have special dietary requirements,who cannot accept a unified diet.
✕. Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting.
✕. Subjects who have received renal transplantation and/or require renal dialysis during the study.
✕. Subjects combined with cardiovascular, respiratory, digestive, endocrine, malignant tumor, hematopoietic, mental/nervous system serious diseases in addition to the disease causing renal dysfunction itself, which are considered not suitable for participation by the investigator.
✕. Subjects with other clinically significant abnormalities except for laboratory tests, physical examination, vital signs, 12-lead electrocardiogram, imaging tests, and abdominal ultrasonography that are judged to be caused by renal insufficiency and its associated diseases, such as ALT (alanine aminotransferase) and/or AST (aspartate aminotransferase) \> 2 times the upper limit of normal and/or TBIL (total bilirubin) \> 1.5 times the upper limit of normal; Hb (hemoglobin) \< 80 g/L; QTc \> 450 ms in men and QTc \> 470 ms in women.
✕. Patients with diabetic nephropathy HbAlc (glycosylated hemoglobin) \> 8.5% or fasting blood glucose \> 8.5 mmol/L, or stable treatment regimen for less than 1 month before screening.
Timeframe: From Day 1 to Day 5
9
Renal Excretion (Ae) of levornidazole
Timeframe: From Day 1 to Day 5
10
renal clearance (CLR) of levornidazole
Timeframe: From Day 1 to Day 5
11
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)