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Hepatic ImpairmentPhase 1NCT07906171

Pharmacokinetics and Safety of Levornidazole Disodium Phosphate for Injection in Chinese Patients With Hepatic Impairment

A Phase 1 study testing Levornidazole Disodium Phosphate for Injection in people with Hepatic Impairment, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective： To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for Injection in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), and healthy subjects. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
Levornidazole Disodium Phosphate for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesChina
Study dates
15 Sep 2023to 4 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Inclusion Criteria （Subjects with Hepatic Impairment）:
  • Male and female subjects aged 18 to 75 years (inclusive);
  • Male subjects with body weight ≥ 50.0 kg and female subjects with body weight ≥ 45.0 kg, with body mass index (BMI) [BMI = weight (kg) / height² (m²)] between 18.0 and 30.0 kg/m² (inclusive);
  • Subjects with hepatic impairment caused by pre-existing primary liver disease (excluding drug-induced liver injury), with Child-Pugh classification of mild (Grade A) or moderate (Grade B);
  • Subjects who have had a stable medication regimen (including drug type, dosage, and frequency) for the treatment of hepatic impairment, complications of liver disease, and other concomitant diseases within 2 weeks prior to check-in or within 5 half-lives of concomitant medications (whichever is longer) through the end of the study period, without requiring adjustment, or subjects who were not on any medication prior to enrollment;
  • Subjects whose hepatic function status is assessed by the investigator as stable from 2 weeks prior to administration of the investigational drug through the end of the study period, without significant deterioration (e.g., abdominal pain, ascites, nausea, vomiting, anorexia, fever, or worsening of liver function-related laboratory results);
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  • Subjects of childbearing potential (including their partners) who voluntarily agree to use appropriate contraceptive measures from 2 weeks prior to screening through 3 months after dosing, and who have no plans for sperm or egg donation;
  • Subjects who are able to understand and are willing to strictly comply with the clinical trial protocol to complete the study, and who have signed the informed consent form.
  • Inclusion Criteria Healthy Subjects:
  • Male and female subjects aged 18 to 75 years (inclusive), matched with subjects in Groups A and B by age and gender;
  • Male subjects with body weight ≥ 50.0 kg and female subjects with body weight ≥ 45.0 kg, with body mass index (BMI) between 18.0 and 30.0 kg/m² (inclusive), matched with subjects in Groups A and B by BMI;
  • Normal hepatic function;
  • Subjects with normal results from medical history inquiry, physical examination, vital sign monitoring, 12-lead electrocardiogram (ECG), laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function), alpha-fetoprotein (AFP), abdominal ultrasound (liver, spleen, gallbladder, pancreas, bilateral kidneys, ascites), and other imaging examinations, or with abnormalities deemed clinically insignificant by the investigator;
  • Subjects of childbearing potential (including their partners) who voluntarily agree to use appropriate contraceptive measures from 2 weeks prior to screening through 3 months after dosing, and who have no plans for sperm or egg donation;
  • Subjects who are able to understand and are willing to strictly comply with the clinical trial protocol to complete the study, and who have signed the informed consent form.

Who cannot join

  • Exclusion Criteria （Subjects with Hepatic Impairment）:
  • Subjects with a confirmed allergy to Levornidazole Disodium Phosphate for Injection or any of its formulation components, or to other nitroimidazole drugs; or those with a history of drug or food allergies, or a history of specific atopic diseases (such as asthma, urticaria, eczema, etc.);
  • Subjects with special dietary requirements who cannot accept a unified diet;
  • Subjects with difficult venous blood sampling, inability to tolerate venipuncture, or a history of needle phobia or blood phobia;
  • Subjects who have undergone surgical procedures within 4 weeks prior to screening, or who plan to undergo surgery during the study period;
  • Subjects with a history of liver transplantation surgery;
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  • Subjects with acute hepatic impairment or liver failure, or those with complications such as hepatic encephalopathy, hepatocellular carcinoma, esophageal and gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, etc.; or subjects with active hepatitis C (those who are HCV-Ab positive but have two HCV-RNA results below the lower limit of detection at an interval of 12 weeks or more may be enrolled); or subjects with active chronic hepatitis B (those who are HBsAg positive, HBeAg negative, and HBV-DNA < 2×10³ IU/mL may be enrolled);
  • Subjects with diseases affecting bile excretion, such as biliary cirrhosis, biliary obstruction, or cholestatic liver disease;
  • Subjects with clinically significant abnormal HIV or syphilis screening results (those with syphilis antibody levels above the normal range but TRUST negative may be enrolled in this study);
  • Subjects with uncontrolled cardiac, respiratory, gastrointestinal, hematological, or neurological diseases, or other medical history that may affect the study results, as judged by the investigator;
  • Subjects whose laboratory test results at screening meet any of the following criteria: (a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 × ULN; (b) Hemoglobin (HGB) < 60 g/L; (c) Abnormal alpha-fetoprotein (AFP) levels suggestive of hepatocellular carcinoma (in combination with other imaging examinations such as liver ultrasound, CT, or MRI);
  • Subjects with uncontrolled or poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • Subjects with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²;
  • Subjects with a history of drug abuse or substance use, or a positive urine drug screening result;
  • Subjects who are regular drinkers within 3 months prior to check-in, i.e., consuming more than 14 units of alcohol per week (1 unit ≈ 360 mL beer, or 45 mL of 40% spirit, or 150 mL wine), or those who cannot abstain from any alcoholic products during the study period, or those with an alcohol breath test result > 0 mg/100 mL;
  • Subjects who have donated blood or experienced significant blood loss (> 400 mL), or received blood transfusions or blood products within 3 months prior to check-in, or those who plan to donate blood during the study period or within 1 month after the end of the study;
  • Subjects who smoke ≥ 5 cigarettes per day within 3 months prior to check-in, or those who do not agree to abstain from any tobacco products during the study period;
  • Subjects who consume excessive tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to check-in, or those who do not agree to abstain from such beverages during the study period;
  • Subjects who have participated in a clinical trial and received an investigational drug within 90 days prior to screening, or those who plan to participate in another clinical trial during the study period;
  • Subjects who have received vaccination within 30 days prior to screening, or those who plan to receive vaccination during the study period;
  • Subjects who have used any drugs that inhibit or induce CYP or UGT enzymes within 30 days prior to check-in;
  • Subjects who have used any prescription drugs, over-the-counter drugs, vitamins, or herbal medicines within 14 days prior to check-in, except for those used to treat hepatic impairment or their concomitant chronic diseases;
  • Subjects who have consumed a special diet (including grapefruit, chocolate, or foods/beverages rich in xanthine) within 48 hours prior to check-in;
  • Female subjects who are lactating or pregnant;
  • Subjects who have developed acute diseases from the screening period to before dosing;
  • Subjects who are deemed unsuitable for inclusion by the investigator.
  • Exclusion Criteria （Healthy Subjects）:
  • Subjects with a confirmed allergy to Levornidazole Disodium Phosphate for Injection or any of its formulation components, or to other nitroimidazole drugs; or those with a history of drug or food allergies, or a history of specific atopic diseases (such as asthma, urticaria, eczema, etc.);
  • Subjects with special dietary requirements who cannot accept a unified diet;
  • Subjects with difficult venous blood sampling, inability to tolerate venipuncture, or a history of needle phobia or blood phobia;
  • Subjects with any clinically significant abnormality in hepatitis B surface antigen (HBsAg), syphilis-specific antibody, human immunodeficiency virus antigen/antibody (HIV Ag/Ab), or hepatitis C virus antibody (HCV-Ab);
  • Subjects with a history of severe diseases of the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, neurological, or psychiatric systems;
  • Subjects who have undergone surgical procedures within 4 weeks prior to screening, or who plan to undergo surgery during the study period;
  • Subjects with a history of drug abuse or substance use, or a positive urine drug screening result;
  • Subjects who are regular drinkers within 3 months prior to check-in, i.e., consuming more than 14 units of alcohol per week (1 unit ≈ 360 mL beer, or 45 mL of 40% spirit, or 150 mL wine), or those who cannot abstain from any alcoholic products during the study period, or those with an alcohol breath test result > 0 mg/100 mL;
  • Subjects who have donated blood or experienced significant blood loss (> 400 mL), or received blood transfusions or blood products within 3 months prior to check-in, or those who plan to donate blood during the study period or within 1 month after the end of the study;
  • Subjects who smoke ≥ 5 cigarettes per day within 3 months prior to check-in, or those who do not agree to abstain from any tobacco products during the study period;
  • Subjects who consume excessive tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to check-in, or those who do not agree to abstain from such beverages during the study period;
  • Subjects who have participated in a clinical trial and received an investigational drug within 90 days prior to screening, or those who plan to participate in another clinical trial during the study period;
  • Subjects who have received vaccination within 30 days prior to screening, or those who plan to receive vaccination during the study period;
  • Subjects who have used any drugs that inhibit or induce CYP or UGT enzymes within 30 days prior to check-in;
  • Subjects who have used any prescription drugs, over-the-counter drugs, health supplements, vitamins, or herbal medicines within 14 days prior to check-in;
  • Subjects who have consumed a special diet (including grapefruit, chocolate, or foods/beverages rich in xanthine) within 48 hours prior to check-in;
  • Female subjects who are lactating or pregnant;
  • Subjects who have developed acute diseases from the screening period to before dosing;
  • Subjects who are deemed unsuitable for inclusion by the investigator.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Chengdu Fifth People's Hospital

    Chengdu

  • Sichuan Provincial People's Hospital

    Chengdu

  • Deyang People's Hospital

    Deyang

Other trials in China

About this study

Official title: A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Levornidazole Disodium Phosphate for Injection in Subjects With Hepatic Impairment: An Open-Label, Parallel, Single-Dose Study

Objective： To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for Injection in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), and healthy subjects.

Being tested
Levornidazole Disodium Phosphate for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levornidazole Disodium Phosphate for InjectionDrug

    Single dose,IV. ,0.5g,60 min（±5 min）

  • Levornidazole Disodium Phosphate for InjectionDrug

    Single dose,IV. ,0.5g，60 min（±5 min）

  • Levornidazole Disodium Phosphate for InjectionDrug

    Single dose,IV. ,0.5g，60 min（±5 min）

Study groups in NCT07906171
Study groupRoleWhat they receive
levornidazole disodium phosphate for Injection (Mild Hepatic Impairment)ExperimentalParticipants with mild hepatic impairment will receive a single dose of levornidazole disodium phosphate for Injection on Day 1.
Receives: Drug: Levornidazole Disodium Phosphate for Injection
levornidazole disodium phosphate for Injection (Moderate Hepatic Impairment)ExperimentalParticipants with Moderate hepatic impairment will receive a single dose of levornidazole disodium phosphate for Injection on Day 1.
Receives: Drug: Levornidazole Disodium Phosphate for Injection
levornidazole disodium phosphate for Injection (Normal Hepatic Function)ExperimentalParticipants with Normal Hepatic Function will receive a single dose of levornidazole disodium phosphate for Injection on Day 1.
Receives: Drug: Levornidazole Disodium Phosphate for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazole

    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

    Measured: From Day 1 to Day 5

  2. Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of levornidazole

    AUCinf is defined as the concentration of drug extrapolated to infinite time.

    Measured: From Day 1 to Day 5

  3. Maximum Observed Plasma Concentration (Cmax) of levornidazole

    Cmax is defined as the maximum concentration of drug.

    Measured: From Day 1 to Day 5

Secondary outcomes (5)

  1. Clearance (CL) of levornidazole

    CL is defined as the clearance following administration of the drug.

    Measured: From Day 1 to Day 5

  2. The Volume of Distribution (Vd) of levornidazole

    Vd is defined as the volume of distribution of the drug.

    Measured: From Day 1 to Day 5

  3. Time of Maximum Observed Plasma Concentration (Tmax) of levornidazole

    Tmax is defined as the time (observed time point) of Cmax.

    Measured: From Day 1 to Day 5

  4. Apparent Terminal Elimination Half-life (t1/2) of levornidazole

    Measured: From Day 1 to Day 5

  5. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 to Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start15 Sep 2023
  3. Primary completion21 Sep 2024
  4. Study completion4 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07906171
Sponsor's protocol ID
YZJ-ZAXZ-402
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Levornidazole Disodium Phosphate for Injection in people with Hepatic Impairment, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazole (time frame: From Day 1 to Day 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07906171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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