Infections Caused by Anaerobic Bacteria, Renal Impairment
Conditions
Brief 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.
Interventions
Single dose, IV
Sponsors
Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
\- Inclusion criteria（Group A and B-Severe Renal Impairment Group and Moderate Renal Impairment Group）: 1. 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. 2. Male or female subjects aged 18-75 years (inclusive). 3. 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). 4. 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. 5. Subjects of childbearing potential (including partners), voluntarily take appropriate contraceptive measures from 2 weeks before screening to 3 months after dosing. Inclusion criteria（Group C-Healthy Subject Group）: 1. 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. 2. 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). 3. 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%). 4. Normal renal function, 90 mL/min ≤ absolute eGFR \< 130 mL/min. 5. Screening physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, imaging and abdominal ultrasonography results were normal or abnormal but the investigator judged no clinical significance. 6. Subjects of childbearing potential (including partners), voluntarily take appropriate contraceptive measures from 2 weeks before screening to 3 months after dosing.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazole | From Day 1 to Day 5 |
| Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of levornidazole | From Day 1 to Day 5 |
| Maximum Observed Plasma Concentration (Cmax) of levornidazole | From Day 1 to Day 5 |
| Clearance (CL) of levornidazole | From Day 1 to Day 5 |
| The Volume of Distribution (Vd) of levornidazole | From Day 1 to Day 5 |
| Time of Maximum Observed Plasma Concentration (Tmax) of levornidazole | From Day 1 to Day 5 |
| Apparent Terminal Elimination Half-life (t1/2) of levornidazole | From Day 1 to Day 5 |
| Mean Residence Time (MRT0-t) of levornidazole | From Day 1 to Day 5 |
| Renal Excretion (Ae) of levornidazole | From Day 1 to Day 5 |
| renal clearance (CLR) of levornidazole | From Day 1 to Day 5 |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 to Day 9 |
Countries
China
Outcome results
None listed