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Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China

Primary Purpose

Influenza, Human

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ZX-7101A 80mg
Sponsored by
Nanjing Zenshine Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza, Human

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: The body mass index (BMI) is 19.0 to 26.0 kg/m2 (including the cut-off), and the subject must weigh no less than 50kg. Before the test, fully understand the test content, process and possible adverse reactions, and voluntarily sign the informed consent. Exclusion Criteria: People with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product. Subjects with a pre-existing or present history of metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease with clinical manifestations that the investigator deems unsuitable for participation in this study. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease. Screening for novel coronavirus infection: Those who are positive for novel coronavirus nucleic acid. Physical examination, vital signs, routine laboratory examination , thyroid function, chest CT, abdominal B-ultrasound and other tests were abnormal with clinical significance. Estimated glomerular filtration rate <90 mL/min/1.73 m2 (see Appendix 1 for eGFR formula). Resting corrected QT interval (QTcF) ≥450ms, QRS≥120ms obtained by 12-lead electrocardiogram (ECG). Any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel. Previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, torsional ventricular tachycardia, ventricular tachycardia, atrioventricular block, history of prolonged QT syndrome, or symptoms of prolonged QT syndrome, and family history (indicated by genetic evidence or by sudden cardiac death at a young age in a close relative). Major surgery or surgical incision not fully healed within 6 months prior to the screening period; Major surgery includes, but is not limited to, any surgery where there is a significant risk of bleeding, prolonged period of general anesthesia, or open biopsy or significant traumatic injury. Use of any P-gp inducer or inhibitor within 30 days prior to the screening period; Have used any prescription drugs or Chinese herbs within 14 days prior to the screening period. Those who consumed more than 14 units of alcohol per week (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) within the six months prior to screening or tested positive for alcohol breath at the screening. Smokers who smoked more than 5 cigarettes a day or habitually used nicotine-containing products within the 3 months before screening and could not quit during the trial period. Subjects who tested serologically positive for antibodies to syphilis (Treponema pallidum), hepatitis B surface antigen or E antigen, hepatitis C virus antibody or human immunodeficiency virus antibody during the screening period. Those who had lost blood or donated 400 mL in the 3 months prior to the screening period or donated >200 mL within 4 weeks or planned to donate blood during the study period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ZX-7101A

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cumulative recovery of total radioactive material in urine and feces
    The total radioactivity in excreta of healthy subjects after oral administration of [14C]ZX-7101A
    Cmax of total radioactivity in plasma
    The peak concentration of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects
    AUC of total radioactivity in plasma
    The area under curve of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects

    Secondary Outcome Measures

    Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
    The Treatment-Related Adverse Events of ZX-7101A will be evaluated by the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.

    Full Information

    First Posted
    January 16, 2023
    Last Updated
    February 6, 2023
    Sponsor
    Nanjing Zenshine Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05720091
    Brief Title
    Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China
    Official Title
    A Study to Evaluate the Substance Balance of [14C] ZX-7101A in Healthy Adult Male Subjects in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 13, 2023 (Anticipated)
    Primary Completion Date
    March 15, 2023 (Anticipated)
    Study Completion Date
    July 8, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing Zenshine Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objectives of this substance balance study in healthy Chinese adult male subjects are to obtain human radioactivity recovery data and major excretion pathways, and to obtain pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the radiometabolite spectrum. The main questions it aims to answer are: Quantitative analysis of total fecal and urine radioactivity in healthy subjects after oral administration of [14C]ZX-7101A to obtain human radioactive recovery data and main excretion routes. Pharmacokinetics of total activity in whole blood and plasma, and distribution of total activity in whole blood and plasma are quantitatively analyzed after oral administration of [14C]ZX-7101A in healthy subjects. Quantitative analysis of the radioactive metabolites in plasma, urine and feces of healthy subjects with once [14C]ZX-7101A orally administration, identification of the main metabolites of the radioactive metabolites (close to or greater than 10% of the total radioactive AUC in plasma), and determination of the main biotransformation and elimination pathway of ZX-7101A.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza, Human

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ZX-7101A
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    ZX-7101A 80mg
    Intervention Description
    a drug to treatment influenza in Chinese adults
    Primary Outcome Measure Information:
    Title
    Cumulative recovery of total radioactive material in urine and feces
    Description
    The total radioactivity in excreta of healthy subjects after oral administration of [14C]ZX-7101A
    Time Frame
    From 1 days before medication to 22 days after medication
    Title
    Cmax of total radioactivity in plasma
    Description
    The peak concentration of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects
    Time Frame
    From 1 days before medication to 22 days after medication
    Title
    AUC of total radioactivity in plasma
    Description
    The area under curve of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects
    Time Frame
    From 1 days before medication to 22 days after medication
    Secondary Outcome Measure Information:
    Title
    Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
    Description
    The Treatment-Related Adverse Events of ZX-7101A will be evaluated by the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.
    Time Frame
    From medication to 22 days after medication

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The body mass index (BMI) is 19.0 to 26.0 kg/m2 (including the cut-off), and the subject must weigh no less than 50kg. Before the test, fully understand the test content, process and possible adverse reactions, and voluntarily sign the informed consent. Exclusion Criteria: People with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product. Subjects with a pre-existing or present history of metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease with clinical manifestations that the investigator deems unsuitable for participation in this study. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease. Screening for novel coronavirus infection: Those who are positive for novel coronavirus nucleic acid. Physical examination, vital signs, routine laboratory examination , thyroid function, chest CT, abdominal B-ultrasound and other tests were abnormal with clinical significance. Estimated glomerular filtration rate <90 mL/min/1.73 m2 (see Appendix 1 for eGFR formula). Resting corrected QT interval (QTcF) ≥450ms, QRS≥120ms obtained by 12-lead electrocardiogram (ECG). Any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel. Previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, torsional ventricular tachycardia, ventricular tachycardia, atrioventricular block, history of prolonged QT syndrome, or symptoms of prolonged QT syndrome, and family history (indicated by genetic evidence or by sudden cardiac death at a young age in a close relative). Major surgery or surgical incision not fully healed within 6 months prior to the screening period; Major surgery includes, but is not limited to, any surgery where there is a significant risk of bleeding, prolonged period of general anesthesia, or open biopsy or significant traumatic injury. Use of any P-gp inducer or inhibitor within 30 days prior to the screening period; Have used any prescription drugs or Chinese herbs within 14 days prior to the screening period. Those who consumed more than 14 units of alcohol per week (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) within the six months prior to screening or tested positive for alcohol breath at the screening. Smokers who smoked more than 5 cigarettes a day or habitually used nicotine-containing products within the 3 months before screening and could not quit during the trial period. Subjects who tested serologically positive for antibodies to syphilis (Treponema pallidum), hepatitis B surface antigen or E antigen, hepatitis C virus antibody or human immunodeficiency virus antibody during the screening period. Those who had lost blood or donated 400 mL in the 3 months prior to the screening period or donated >200 mL within 4 weeks or planned to donate blood during the study period.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    liao, doctor
    Phone
    0512-67972858
    Email
    miaolysuzhou@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    liao, liao
    Organizational Affiliation
    Suzhou university affiliated hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China

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