search
Back to results

Pharmacokinetic Characteristics of Subjects With Hepatic Insufficiency and Healthy Subjects

Primary Purpose

Influenza, Human

Status
Recruiting
Phase
Phase 1
Locations
China
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 - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The presence of cirrhosis was confirmed by CT, magnetic resonance imaging (MRI), liver biopsy or noninvasive hepatic fibrosis test. The subject was determined to have liver insufficiency based on A Grade A or B on the Child-Pugh scale. If the subject has hepatic encephalopathy, the investigator determines that the current condition will not interfere with the subject's ability to provide appropriate informed consent. Exclusion Criteria: Previous or present history of respiratory, blood, cardiovascular, digestive, urinary, endocrine and metabolic, neurological or psychiatric disorders with clinical manifestations. 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. A history of gastrointestinal surgery or excision may interfere with oral drug absorption and/or excretion Patients with abnormal vital signs at screening visit and baseline visit: ear temperature > 37.5℃, pulse rate > 100 beats/min or < 50 beats/min, systolic blood pressure ≥140 mmHg or < 90 mmHg, diastolic blood pressure ≥90 mmHg or < 50mmHg. Participated in clinical studies of any drug or medical device within 3 months prior to screening, and participated in clinical studies of drug for 3 or more times within the last year. Severe infection, trauma, or major surgery within 4 weeks prior to screening, or clinically significant (as determined by the investigator) acute illness such as gastrointestinal disease, infection (e.g. respiratory or central nervous system infection, and idiopathic peritonitis) within 2 weeks prior to screening. Had used any prescription drugs, Chinese herbs, or over-the-counter drugs (except birth control pills, acetaminophen, and topical over-the-counter preparations) in the 2 weeks prior to enrollment; Unless the principal investigator (PI) and the sponsor agree that the drug used has no impact on the safety and PK results of the study; If the combined drug has a longer half-life (more than 3 days), the required time interval will be longer and should be at least 5 half-lives of the drug. Smoking averaged more than 5 cigarettes per day in the 3 months prior to screening, or could not stop using any tobacco products during the study period. Persons who consumed more than 14 units of alcohol per week (1 unit = 360mL beer, 150 mL wine or 45 mL 40% spirits) in the 3 months prior to the screening period, or who had a positive alcohol breath test (screening period or baseline period), or who could not abstain during the study period. Test positive for hepatitis B (HBV) surface antigen, hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody or treponema pallidum antibody. Subjects with a history of substance abuse (e.g., morphine, dimethyldioxyamphetamine, methylamphetamine, tetrahydrocannabinol, ketamine, cocaine) or who screened positive for substance abuse. Those who received the vaccine within 30 days prior to administration or who planned to receive the vaccine during the study period. Donors who donated > 400 mL within 3 months prior to the screening period or > 200 mL within 4 weeks or planned to donate blood during the study period. Patients with difficulty in venous blood collection. Vigorous exercise should not be prohibited within 48 hours before and during the study period. It is expected that patients may be scheduled for surgery or hospitalization during the study. Any other circumstances which, in the opinion of the investigator, may affect the subject's ability to provide informed consent or to follow the protocol of the study, to complete the study in accordance with the study procedure, or the subject's participation in the study may affect the results of the study or his or her own safety.

Sites / Locations

  • Shuguang Hospital, Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ZX-7101A 80mg Mild or moderate liver insufficiency

ZX-7101A 80mg Normal liver function

Arm Description

Outcomes

Primary Outcome Measures

Cmax
To evaluate the peak concentration of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency
AUC
To evaluate the area under curve of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency

Secondary Outcome Measures

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 after a single oral administration ZX-7101A
The Number of Participants with Treatment-Related Adverse Events will be evaluated as 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 2, 2023
Sponsor
Nanjing Zenshine Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05711797
Brief Title
Pharmacokinetic Characteristics of Subjects With Hepatic Insufficiency and Healthy Subjects
Official Title
An Open, Parallel Study Evaluating the Pharmacokinetic Profile, Safety, and Tolerability of a Single Oral Dose of ZX-7101A Tablets in Subjects With Mild or Moderate Liver Insufficiency and Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (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 objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects. The main questions it aims to answer are: Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver dysfunction and healthy subjects with normal liver function matched for age, weight, and sex. To evaluate the safety and tolerability of ZX-7101A by a single oral dose in subjects.

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
Parallel Assignment
Model Description
80mg ZX-7101A
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZX-7101A 80mg Mild or moderate liver insufficiency
Arm Type
Experimental
Arm Title
ZX-7101A 80mg Normal liver function
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZX-7101A 80mg
Intervention Description
ZX-7101A a drug to treatment influenza in Chinese adults
Primary Outcome Measure Information:
Title
Cmax
Description
To evaluate the peak concentration of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency
Time Frame
From dosing to 15 days after medication
Title
AUC
Description
To evaluate the area under curve of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency
Time Frame
From dosing to 15 days after medication
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 after a single oral administration ZX-7101A
Description
The Number of Participants with Treatment-Related Adverse Events will be evaluated as the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.
Time Frame
From dosing to 29 days after medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The presence of cirrhosis was confirmed by CT, magnetic resonance imaging (MRI), liver biopsy or noninvasive hepatic fibrosis test. The subject was determined to have liver insufficiency based on A Grade A or B on the Child-Pugh scale. If the subject has hepatic encephalopathy, the investigator determines that the current condition will not interfere with the subject's ability to provide appropriate informed consent. Exclusion Criteria: Previous or present history of respiratory, blood, cardiovascular, digestive, urinary, endocrine and metabolic, neurological or psychiatric disorders with clinical manifestations. 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. A history of gastrointestinal surgery or excision may interfere with oral drug absorption and/or excretion Patients with abnormal vital signs at screening visit and baseline visit: ear temperature > 37.5℃, pulse rate > 100 beats/min or < 50 beats/min, systolic blood pressure ≥140 mmHg or < 90 mmHg, diastolic blood pressure ≥90 mmHg or < 50mmHg. Participated in clinical studies of any drug or medical device within 3 months prior to screening, and participated in clinical studies of drug for 3 or more times within the last year. Severe infection, trauma, or major surgery within 4 weeks prior to screening, or clinically significant (as determined by the investigator) acute illness such as gastrointestinal disease, infection (e.g. respiratory or central nervous system infection, and idiopathic peritonitis) within 2 weeks prior to screening. Had used any prescription drugs, Chinese herbs, or over-the-counter drugs (except birth control pills, acetaminophen, and topical over-the-counter preparations) in the 2 weeks prior to enrollment; Unless the principal investigator (PI) and the sponsor agree that the drug used has no impact on the safety and PK results of the study; If the combined drug has a longer half-life (more than 3 days), the required time interval will be longer and should be at least 5 half-lives of the drug. Smoking averaged more than 5 cigarettes per day in the 3 months prior to screening, or could not stop using any tobacco products during the study period. Persons who consumed more than 14 units of alcohol per week (1 unit = 360mL beer, 150 mL wine or 45 mL 40% spirits) in the 3 months prior to the screening period, or who had a positive alcohol breath test (screening period or baseline period), or who could not abstain during the study period. Test positive for hepatitis B (HBV) surface antigen, hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody or treponema pallidum antibody. Subjects with a history of substance abuse (e.g., morphine, dimethyldioxyamphetamine, methylamphetamine, tetrahydrocannabinol, ketamine, cocaine) or who screened positive for substance abuse. Those who received the vaccine within 30 days prior to administration or who planned to receive the vaccine during the study period. Donors who donated > 400 mL within 3 months prior to the screening period or > 200 mL within 4 weeks or planned to donate blood during the study period. Patients with difficulty in venous blood collection. Vigorous exercise should not be prohibited within 48 hours before and during the study period. It is expected that patients may be scheduled for surgery or hospitalization during the study. Any other circumstances which, in the opinion of the investigator, may affect the subject's ability to provide informed consent or to follow the protocol of the study, to complete the study in accordance with the study procedure, or the subject's participation in the study may affect the results of the study or his or her own safety.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xian yu huang, doctor
Phone
13671712162
Email
Zhangj_fudan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
jing zhang, doctor
Phone
52887926
Email
yxhuang@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian yu huang, doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuan, doctor
Phone
20256052
Email
Weian_yuan1980@163.com
First Name & Middle Initial & Last Name & Degree
zhu, doctor
Phone
20256052
Email
Zhuleilei1981@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pharmacokinetic Characteristics of Subjects With Hepatic Insufficiency and Healthy Subjects

We'll reach out to this number within 24 hrs