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A Study in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Primary Purpose

Subjects With Renal Impairment, Healthy Subjects

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Deuremidevir Hydrobromide Tablets
Sponsored by
Shanghai Vinnerna Biosciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Subjects With Renal Impairment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Sign an informed consent form before the experiment and have a thorough understanding of the content, process, and potential adverse reactions of the experiment; 18 years old ≤ age ≤ 65 years old, regardless of gender; Body mass index (BMI) within the range of 19 kg/m2 to 28 kg/m2 (including both end values); Subjects with renal insufficiency: The estimated glomerular filtration rate (eGFR, calculated using the CKD-EPI formula (refer to Attachment 3)) must meet the following criteria: Subjects with mild renal insufficiency (CKD2 stage): 60-89 mL/min/1.73m2 (including both end values) Subjects with moderate renal insufficiency (CKD3 phase): 30-59 mL/min/1.73m2 (including both end values) Healthy subjects: estimated Glomerular filtration rate (eGFR, calculated using the CKD-EPI (refer to Appendix 3) formula) ≥ 90 mL/min/1.73m2; Subjects with renal insufficiency: The renal function status is stable, and the eGFR results of the two tests before administration (with an interval of at least 3 days between the two tests) must be within the same CKD stage; Exclusion Criteria: Subjects with renal insufficiency who meet any of the following criteria will not be eligible for admission to this study: had a kidney transplant before; Kidney dialysis is required during the study period; Urinary incontinence or anuria; Individuals who are allergic to research drugs or excipients; Having clinically significant heart disease within 12 months prior to the start of treatment, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF ≥ 470 ms (female) or 450 ms (male), etc; Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 × ULN), or screening for clinically significant bleeding symptoms or clear bleeding tendencies within the first 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, or undergoing thrombolytic and anticoagulant treatment; Patients with hypertension, diabetes, hyperlipidemia and other basic diseases, who cannot be well controlled after drug treatment (including systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg); Used 14 days before taking the study drug, or needed to be used during the test, any drug that affects the secretion of gastric acid, including but not limited to cimetidine, ranitidine, famotidine, rosatidine, nizatidine, omeprazole, lansoprazole, pirenzepine, rabeprazole, pantoprazole, aluminum hydroxide, etc; Or any Chinese medicine or traditional Chinese patent medicines and simple preparations needs to be used after signing the informed consent form to the end of PK blood collection; Healthy subjects who meet any of the following criteria are not eligible to participate in this study: Those who have definite diseases such as central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. and need medical intervention or other diseases that are not suitable for clinical trials (such as psychiatric history, etc.); Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within the first 2 weeks of screening; Those who are screened positive for urinary drug abuse, or have a history of drug abuse within the past five years or have used drugs in the past three months before the trial; Positive individuals for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti HCV), treponema pallidum antibody, and acquired immunodeficiency syndrome (HIV) antibody; Abnormal chest X-ray (posterior anterior position) results with clinical significance; B-ultrasound examination shows moderate to severe fatty liver disease; When screening or baseline alanine transaminase (ALT) or aspartate transaminase (AST) exceeded the upper limit of normal value (ULN); During screening or baseline electrocardiogram abnormalities, QTcF (corrected for heart rate) in a single examination for males>450 ms, females>470 ms, and/or other clinically significant abnormalities;

Sites / Locations

  • Shanghai Xuhui Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Mild Renal Impairment

Moderate Renal Impairment

Healthy subjects

Outcomes

Primary Outcome Measures

Evaluate the impact on the Cmax of the main metabolite 116-N1 of JT001;
maximum observed plasma concentration
Evaluate the impact on the AUC0-t of the main metabolite 116-N1 of JT001;
area under the plasma concentration time curve from time zero to the last measurable concentration
Evaluate the impact on the AUC0-inf of the main metabolite 116-N1 of JT001;
area under the plasma concentration-time curve from time zero to infinity
Tmax of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Tmax of the main metabolite 116-N1 of JT001;
t1/2 of the main metabolite 116-N1 of JT001;
Evaluate the impact on the t1/2 of the main metabolite 116-N1 of JT001;
CL/F of the main metabolite 116-N1 of JT001;
Evaluate the impact on the CL/F of the main metabolite 116-N1 of JT001;
Vz/F of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Vz/F of the main metabolite 116-N1 of JT001;
Ae of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Ae of the main metabolite 116-N1 of JT001;
CLr of the main metabolite 116-N1 of JT001;
Evaluate the impact on the CLr of the main metabolite 116-N1 of JT001;
Ae% of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Ae% of the main metabolite 116-N1 of JT001;

Secondary Outcome Measures

The incidence and severity of adverse events (TEAEs) of serious adverse events (SAE) occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of serious adverse events (SAE) occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of clinical symptoms occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of clinical symptoms occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of vital signs occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of vital signs occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of physical examination occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of physical examination occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of laboratory examination occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of laboratory examination occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of abnormal electrocardiogram (ECG) occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of abnormal electrocardiogram (ECG) occurred during the treatment were observed.

Full Information

First Posted
May 15, 2023
Last Updated
September 25, 2023
Sponsor
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborators
Sponsor GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05895812
Brief Title
A Study in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
Official Title
A Non-Random, Open-label, Parallel-group Study to Assess the Pharmacokinetics of JT001 in Subjects With Mild and Moderate Renal Impairment Compared to Subjects With Normal Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
August 25, 2023 (Actual)
Study Completion Date
August 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Vinnerna Biosciences Co., Ltd.
Collaborators
Sponsor GmbH

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 purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of JT001 in adult subjects with mild and moderate renal impairment compared to healthy mean-matched subjects.The results of this study will guide the clinical recommendation regarding whether or not a dose adjustment may be needed when treating patients with renal impairment.
Detailed Description
This study will compare the pharmacokinetics of JT001 in patients with normal, mild or moderate renal impairment.There are 3 periods in the study including screening(D-28~D-1 prior to investigation product administration) 、treatment and assessment (D1~D4 domiciled in study center) and telephone follow-up(D7). Twenty-four males and female volunteers between 18-65 years of age with BMI between 19- 28 kg/m2 will be divided into 3 groups of 8 subjects each based on renal function as defined (8 normal, 8 mild impairment, 8 moderate impairment).Participants in the renal impairment groups will be staged by their respective degree of renal function (mild or moderate) according to the estimated glomerular filtration rate (eGFR) determined at the screening visit. In order to exclude other factors that may affect the nature of PK, each renal impairment participant must be matched to a healthy control participant with respect to gender、age (±10 years) and body weight (±10kg).The subjects received a single dose of JT001 and collected blood and urine samples before and after administration for pharmacokinetic analysis. After enrollment,subjects will be confined to the study unit during the entire 4 day study period.On day 1, after a fast of at least 10 hours, each patient will receive a single oral dose 0.3g of JT001. Blood and urine samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite(116N-1) in the three study groups. Subjects will be monitored regarding adverse effects throughout study participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects With Renal Impairment, Healthy Subjects

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Mild Renal Impairment
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Moderate Renal Impairment
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Healthy subjects
Intervention Type
Drug
Intervention Name(s)
Deuremidevir Hydrobromide Tablets
Intervention Description
JT001 single dose, 0.3g
Primary Outcome Measure Information:
Title
Evaluate the impact on the Cmax of the main metabolite 116-N1 of JT001;
Description
maximum observed plasma concentration
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
Evaluate the impact on the AUC0-t of the main metabolite 116-N1 of JT001;
Description
area under the plasma concentration time curve from time zero to the last measurable concentration
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
Evaluate the impact on the AUC0-inf of the main metabolite 116-N1 of JT001;
Description
area under the plasma concentration-time curve from time zero to infinity
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
Tmax of the main metabolite 116-N1 of JT001;
Description
Evaluate the impact on the Tmax of the main metabolite 116-N1 of JT001;
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
t1/2 of the main metabolite 116-N1 of JT001;
Description
Evaluate the impact on the t1/2 of the main metabolite 116-N1 of JT001;
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
CL/F of the main metabolite 116-N1 of JT001;
Description
Evaluate the impact on the CL/F of the main metabolite 116-N1 of JT001;
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
Vz/F of the main metabolite 116-N1 of JT001;
Description
Evaluate the impact on the Vz/F of the main metabolite 116-N1 of JT001;
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
Ae of the main metabolite 116-N1 of JT001;
Description
Evaluate the impact on the Ae of the main metabolite 116-N1 of JT001;
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
CLr of the main metabolite 116-N1 of JT001;
Description
Evaluate the impact on the CLr of the main metabolite 116-N1 of JT001;
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Title
Ae% of the main metabolite 116-N1 of JT001;
Description
Evaluate the impact on the Ae% of the main metabolite 116-N1 of JT001;
Time Frame
From time zero up to 72 hours post-dose following oral administration of JT001
Secondary Outcome Measure Information:
Title
The incidence and severity of adverse events (TEAEs) of serious adverse events (SAE) occurred during the treatment were observed.
Description
The incidence and severity of adverse events (TEAEs) of serious adverse events (SAE) occurred during the treatment were observed.
Time Frame
From Day 1(first dose) to Day7
Title
The incidence and severity of adverse events (TEAEs) of clinical symptoms occurred during the treatment were observed.
Description
The incidence and severity of adverse events (TEAEs) of clinical symptoms occurred during the treatment were observed.
Time Frame
From Day 1(first dose) to Day7
Title
The incidence and severity of adverse events (TEAEs) of vital signs occurred during the treatment were observed.
Description
The incidence and severity of adverse events (TEAEs) of vital signs occurred during the treatment were observed.
Time Frame
From Day 1(first dose) to Day7
Title
The incidence and severity of adverse events (TEAEs) of physical examination occurred during the treatment were observed.
Description
The incidence and severity of adverse events (TEAEs) of physical examination occurred during the treatment were observed.
Time Frame
From Day 1(first dose) to Day7
Title
The incidence and severity of adverse events (TEAEs) of laboratory examination occurred during the treatment were observed.
Description
The incidence and severity of adverse events (TEAEs) of laboratory examination occurred during the treatment were observed.
Time Frame
From Day 1(first dose) to Day7
Title
The incidence and severity of adverse events (TEAEs) of abnormal electrocardiogram (ECG) occurred during the treatment were observed.
Description
The incidence and severity of adverse events (TEAEs) of abnormal electrocardiogram (ECG) occurred during the treatment were observed.
Time Frame
From Day 1(first dose) to Day7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sign an informed consent form before the experiment and have a thorough understanding of the content, process, and potential adverse reactions of the experiment; 18 years old ≤ age ≤ 65 years old, regardless of gender; Body mass index (BMI) within the range of 19 kg/m2 to 28 kg/m2 (including both end values); Subjects with renal insufficiency: The estimated glomerular filtration rate (eGFR, calculated using the CKD-EPI formula (refer to Attachment 3)) must meet the following criteria: Subjects with mild renal insufficiency (CKD2 stage): 60-89 mL/min/1.73m2 (including both end values) Subjects with moderate renal insufficiency (CKD3 phase): 30-59 mL/min/1.73m2 (including both end values) Healthy subjects: estimated Glomerular filtration rate (eGFR, calculated using the CKD-EPI (refer to Appendix 3) formula) ≥ 90 mL/min/1.73m2; Subjects with renal insufficiency: The renal function status is stable, and the eGFR results of the two tests before administration (with an interval of at least 3 days between the two tests) must be within the same CKD stage; Exclusion Criteria: Subjects with renal insufficiency who meet any of the following criteria will not be eligible for admission to this study: had a kidney transplant before; Kidney dialysis is required during the study period; Urinary incontinence or anuria; Individuals who are allergic to research drugs or excipients; Having clinically significant heart disease within 12 months prior to the start of treatment, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF ≥ 470 ms (female) or 450 ms (male), etc; Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 × ULN), or screening for clinically significant bleeding symptoms or clear bleeding tendencies within the first 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, or undergoing thrombolytic and anticoagulant treatment; Patients with hypertension, diabetes, hyperlipidemia and other basic diseases, who cannot be well controlled after drug treatment (including systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg); Used 14 days before taking the study drug, or needed to be used during the test, any drug that affects the secretion of gastric acid, including but not limited to cimetidine, ranitidine, famotidine, rosatidine, nizatidine, omeprazole, lansoprazole, pirenzepine, rabeprazole, pantoprazole, aluminum hydroxide, etc; Or any Chinese medicine or traditional Chinese patent medicines and simple preparations needs to be used after signing the informed consent form to the end of PK blood collection; Healthy subjects who meet any of the following criteria are not eligible to participate in this study: Those who have definite diseases such as central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. and need medical intervention or other diseases that are not suitable for clinical trials (such as psychiatric history, etc.); Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within the first 2 weeks of screening; Those who are screened positive for urinary drug abuse, or have a history of drug abuse within the past five years or have used drugs in the past three months before the trial; Positive individuals for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti HCV), treponema pallidum antibody, and acquired immunodeficiency syndrome (HIV) antibody; Abnormal chest X-ray (posterior anterior position) results with clinical significance; B-ultrasound examination shows moderate to severe fatty liver disease; When screening or baseline alanine transaminase (ALT) or aspartate transaminase (AST) exceeded the upper limit of normal value (ULN); During screening or baseline electrocardiogram abnormalities, QTcF (corrected for heart rate) in a single examination for males>450 ms, females>470 ms, and/or other clinically significant abnormalities;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiyu Lan, Project Director
Organizational Affiliation
Shanghai Vinnerna Biosciences Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Xuhui Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided

Learn more about this trial

A Study in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

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