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

NCT07033182 | Completed Phase 1

• 1 other identifier: YZJ-ZAXZ-403
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections Caused by Anaerobic Bacteria; Renal Impairment

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (3)

Experimental Group A

EXPERIMENTAL

Severe renal impairment

Drug: Levornidazole Disodium Phosphate for Injection

Experimental Group B

EXPERIMENTAL

Moderate renal impairment

Drug: Levornidazole Disodium Phosphate for Injection

Experimental Group C

EXPERIMENTAL

Normal renal function

Drug: Levornidazole Disodium Phosphate for Injection

Interventions

Levornidazole Disodium Phosphate for Injection DRUG

Single dose, IV

Experimental Group A; Experimental Group B; Experimental Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• Normal renal function, 90 mL/min ≤ absolute eGFR \< 130 mL/min.
• 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.
• Subjects of childbearing potential (including partners), voluntarily take appropriate contraceptive measures from 2 weeks before screening to 3 months after dosing.

You may not qualify if:

• 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.).
• 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.
• Subjects with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or heart rate \> 120 bmp.
• 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.
• 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.
• Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening.
• Subjects who frequently consume alcohol within 3 months prior to screening, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits, or 150 mL of wine), or who cannot stop using any alcohol products during the study, or alcohol breath test result \> 0.0 mg/100 mL.
• Subjects who have donated blood or experienced massive blood loss (\> 400 mL) within 3 months prior to screening, received blood transfusions or used blood products, planned to donate blood during the trial period or within 1 month after the end of the trial.
• Subjects who have consumed excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup ≈ 250 mL) daily during the 3 months before screening.
• Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or those who cannot stop using any tobacco products during the study.
• Subjects who have participated in any clinical trial within 3 months prior to screening, or plan to participate in other clinical trials during the study.

Sponsors & Collaborators

• Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Beijing Haisha Consulting Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Injections

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: October 30, 2023
• Primary Completion: April 7, 2024
• Study Completion: July 31, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)