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Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects With Renal Impairment and Normal Renal Impairment | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects With Renal Impairment and Normal Renal Impairment

An Open-Label, Parallel, Single-Dose Study to Assess the Pharmacokinetics and Safety of Levornidazole Disodium Phosphate for Injection in Subjects With Varying Degrees of Renal Impairment

NCT07033182•Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•\-
•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.
•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.
+2 more criteria

Exclusion Criteria

•\-
•1. 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.).
•2. Subjects who have special dietary requirements,who cannot accept a unified diet.
•3. Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting.
•4. Subjects who have received renal transplantation and/or require renal dialysis during the study.
•5. 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.
•6. 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.
•7. Subjects with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or heart rate \> 120 bmp.
•8. 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.
•9. Subjects with clinically significant abnormalities in any of hepatitis B virus surface antigen, Treponema pallidum-specific antibody, human immunodeficiency virus antibody, hepatitis C virus antibody.
+36 more criteria

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Key Dates

Start Date

October 30, 2023

Primary Completion Date

April 7, 2024

Completion Date

July 31, 2024

Last Updated

June 24, 2025

Enrollment

ACTUAL participants

Conditions

Infections Caused by Anaerobic BacteriaRenal Impairment

Interventions

Levornidazole Disodium Phosphate for Injection

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects With Renal Impairment and Normal Renal Impairment

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure