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Mass Balance StudyPhase 1NCT07906197

A Mass Balance Study on [14C]Levornidazole Disodium Phosphate for Injection in Healthy Chinese Adult Male Subjects

A Phase 1 study testing Levornidazole Disodium Phosphate for Injection in people with Mass Balance Study, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 1 site 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

To quantitatively analyze the total radioactivity in excreta from healthy male subjects following a single intravenous infusion of [14C]levornidazole disodium phosphate, and to semi-quantitatively estimate the recovery of 14CO₂ in exhaled breath, thereby obtaining the human radioactivity recovery data and identifying… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Mass Balance Study
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
6 participants
Where
1 siteChina
Study dates
30 Oct 2024to 14 Feb 2025
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects aged 18 to 45 years (inclusive);
  • Body weight ≥ 50.0 kg, with body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive);
  • Subjects must be fully informed of the study and voluntarily sign the written informed consent form prior to the start of the study;
  • Subjects who have no plan for fertility or sperm donation during the study period and within 1 year after completion of the study, and who agree to adopt strict contraceptive measures together with their sexual partners;
  • Subjects with good hygiene habits, who are able to communicate well with the investigator and complete the study in accordance with the protocol requirements.

Who cannot join

  • Subjects with clinically significant abnormal findings from vital sign measurements, physical examination, laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function, thyroid function, fecal occult blood), 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), or abdominal ultrasound (liver, gallbladder, pancreas, spleen, and kidneys) at screening, as judged by the investigator;
  • Subjects with any positive result for hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg), hepatitis C virus antibody IgG (HCV-Ab IgG), HIV antigen/antibody (HIV Ag/Ab), or Treponema pallidum antibody;
  • Subjects who have participated in any clinical trial and received an investigational drug or investigational medical device within 3 months prior to screening;
  • Subjects who have used any drugs that inhibit or induce CYP or UGT enzymes within 4 weeks prior to screening;
  • Subjects who have used any prescription drugs, over-the-counter drugs, vitamin products, health supplements, or herbal medicines within 14 days prior to screening;
  • Subjects with habitual constipation or diarrhea;
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  • Subjects with hemorrhoids or perianal diseases accompanied by regular/ongoing hematochezia, irritable bowel syndrome, or inflammatory bowel disease;
  • Subjects with atopic constitution, including a history of severe drug allergy or drug hypersensitivity, known allergy to the investigational product or to levofosfomycin, ornidazole, other nitroimidazole drugs or their excipients, or a history of food allergy;
  • Subjects who have undergone major surgery within 6 months prior to screening or whose surgical incisions have not completely healed; major surgery includes but is not limited to any surgery with significant bleeding risk, prolonged general anesthesia, or open biopsy, or significant traumatic injury;
  • Subjects with a history of any clinically significant disease or condition that may affect the study results, as judged by the investigator, including but not limited to diseases of the respiratory, cardiovascular, digestive, endocrine, neurological (e.g., epilepsy), urinary, hematological, immune, psychiatric, or metabolic systems;
  • Subjects who are regular drinkers within 6 months prior to screening, 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 with alcoholism; or those with an alcohol breath test result > 20 mg/dL at screening; or those who cannot abstain from alcohol during the study period;
  • Subjects who smoke more than 5 cigarettes per day or habitually use nicotine-containing products within 3 months prior to screening, and who cannot abstain during the study period;
  • Subjects who have used soft drugs (e.g., cannabis) within 3 months prior to screening or hard drugs (e.g., amphetamines, phencyclidine, etc.) within 1 year prior to screening; or those with a history of drug abuse; or those with a positive urine drug screening result at screening;
  • Subjects who have consumed grapefruit, pomelo, dragon fruit, mango, or other fruits/products that affect metabolic enzymes within 7 days prior to screening;
  • Subjects who habitually consume any foods or beverages rich in caffeine or xanthine (coffee, tea, cola, chocolate, etc.), or those who do not agree to abstain from such foods or beverages during the study period;
  • Subjects with special dietary requirements who cannot comply with the unified diet;
  • Subjects with a history of needle phobia or blood phobia, or those with difficulty in blood sampling or inability to tolerate venipuncture;
  • Subjects engaged in occupations requiring long-term exposure to radioactive conditions; or those with significant radiation exposure within 1 year prior to the study (≥ 2 chest/abdominal CT scans, or ≥ 3 other types of X-ray examinations) or those who have participated in radiolabeled drug trials;
  • Subjects who have donated blood with a total volume ≥ 400 mL or experienced total blood loss ≥ 400 mL within 3 months prior to screening, or donated blood with a total volume ≥ 200 mL or experienced total blood loss ≥ 200 mL or received blood transfusion within 1 month prior to screening, or those who plan to donate blood within 1 month after the end of this study;
  • Subjects who are deemed by the investigator to have other factors that make them unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou

Other trials in China

About this study

Official title: Study on [14C] Levornidazole Disodium Phosphate for Injection in Healthy Chinese Adult Male Subjects

To quantitatively analyze the total radioactivity in excreta from healthy male subjects following a single intravenous infusion of [14C]levornidazole disodium phosphate, and to semi-quantitatively estimate the recovery of 14CO₂ in exhaled breath, thereby obtaining the human radioactivity recovery data and identifying the major routes of excretion; To analyze the radioactive metabolite profiles in human plasma, urine, and feces from healthy male subjects following a single intravenous infusion of [14C]levornidazole disodium phosphate, to identify the major metabolites, and to determine the metabolic pathways and elimination routes of levornidazole disodium phosphate in humans; To quantitatively analyze the total radioactivity in whole blood and plasma from healthy male subjects following a single intravenous infusion of [14C]levornidazole disodium phosphate, to obtain the pharmacokinetic parameters of total radioactivity in plasma, and to investigate the distribution of total radioactivity between whole blood and plasma.

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

    D1: 0.5g/30 µCi [14C] levornidazole disodium phosphate Single dose

Study groups in NCT07906197
Study groupRoleWhat they receive
30µCi [14C]levornidazole disodium phosphateExperimentalOn the morning of Day 1, after breakfast, subjects will receive a 60-minute (± 5 min) intravenous infusion of 100 mL of 0.9% NaCl solution containing 0.5 g (calculated as levofosfomycin) / 30 µCi of [14C] levornidazole disodium phosphate
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. Cumulative Percent Recovery of Total Radiocarbon (14C)

    Percentage recovery of total radioactivity (14C) in urine, feces, and exhale was determined based on total administered dose.

    Measured: From Day 1 to Day 10

  2. Percentage of Metabolite Detected in Plasma ，Urine, Feces

    The percentage of major metabolites detected in plasma urine, feces following [14C]levornidazole disodium phosphate single dose administration

    Measured: From Day 1 to Day 10

  3. 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 10

  4. 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 10

  5. Maximum Observed Plasma Concentration (Cmax) of levornidazole

    Cmax is defined as the maximum concentration of drug.

    Measured: From Day 1 to Day 10

Secondary outcomes (6)

  1. Clearance (CL) of levornidazole

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

    Measured: From Day 1 to Day 10

  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 10

  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 10

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

    Measured: From Day 1 to Day 10

  5. Mean Residence Time (MRT0-t) of levornidazole

    Measured: From Day 1 to Day 10

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

    Measured: From Day 1 to Day 10

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 start30 Oct 2024
  3. Primary completion5 Dec 2024
  4. Study completion14 Feb 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07906197
Sponsor's protocol ID
YZJ-ZAXZ-405
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 Mass Balance Study, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 1 site 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 5 inclusion and 20 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 1 site 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?

Cumulative Percent Recovery of Total Radiocarbon (14C) (time frame: From Day 1 to Day 10). The study lists 5 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 NCT07906197.

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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