Subjects With Renal ImpairmentPhase 1NCT05895812

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

A Phase 1 study testing Deuremidevir Hydrobromide Tablets in people with Subjects With Renal Impairment and Healthy Subjects, run by Shanghai Vinnerna Biosciences 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

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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Subjects With Renal Impairment, Healthy Subjects
What is being tested?: Deuremidevir Hydrobromide Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 8 May 2023to 28 Aug 2023
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

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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;

Who cannot join

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;

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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;

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

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

Read the 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.

Conditions: Subjects With Renal Impairment, Healthy Subjects
Being tested: Deuremidevir Hydrobromide Tablets

What participants receive

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

Deuremidevir Hydrobromide TabletsDrug
JT001 single dose, 0.3g

Study groups in NCT05895812
Study group	Role	What they receive
Arm 1	Experimental	Mild Renal Impairment Receives: Drug: Deuremidevir Hydrobromide Tablets
Arm 2	Experimental	Moderate Renal Impairment Receives: Drug: Deuremidevir Hydrobromide Tablets
Arm 3	Experimental	Healthy subjects Receives: Drug: Deuremidevir Hydrobromide Tablets

What is being measured

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

Evaluate the impact on the Cmax of the main metabolite 116-N1 of JT001;
maximum observed plasma concentration
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
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
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
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
Measured: From time zero up to 72 hours post-dose following oral administration of JT001
Tmax of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Tmax of the main metabolite 116-N1 of JT001;
Measured: From time zero up to 72 hours post-dose following oral administration 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;
Measured: From time zero up to 72 hours post-dose following oral administration 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;
Measured: From time zero up to 72 hours post-dose following oral administration 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;
Measured: From time zero up to 72 hours post-dose following oral administration 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;
Measured: From time zero up to 72 hours post-dose following oral administration 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;
Measured: From time zero up to 72 hours post-dose following oral administration 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;
Measured: From time zero up to 72 hours post-dose following oral administration of JT001

Secondary outcomes (6)

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.
Measured: From Day 1(first dose) to Day7
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.
Measured: From Day 1(first dose) to Day7
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.
Measured: From Day 1(first dose) to Day7
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.
Measured: From Day 1(first dose) to Day7
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.
Measured: From Day 1(first dose) to Day7
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.
Measured: From Day 1(first dose) to Day7

Timeline

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

8 May 202328 Aug 2023

First posted9 Jun 2023
Study start8 May 2023
Primary completion25 Aug 2023
Study completion28 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Subjects With Renal ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Parallel
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05895812
Sponsor's protocol ID: JT001-008-I
Status last verified: May 2023
First submitted: 15 May 2023
Last updated: 26 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Subjects With Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05895812
Acronym / sponsor ID: JT001-008-I
Conditions: Subjects With Renal Impairment, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Sponsor GmbH
Study start: 8 May 2023 (actual)
Primary completion: 25 Aug 2023 (actual)
Study completion: 28 Aug 2023 (actual)
First posted: 9 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Parallel

Arm	Type	Receives
Arm 1	Experimental	Drug: Deuremidevir Hydrobromide TabletsMild Renal Impairment
Arm 2	Experimental	Drug: Deuremidevir Hydrobromide TabletsModerate Renal Impairment
Arm 3	Experimental	Drug: Deuremidevir Hydrobromide TabletsHealthy subjects

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Deuremidevir Hydrobromide TabletsJT001 single dose, 0.3g	Drug	Arm 1, Arm 2, Arm 3

Primary outcome

Evaluate the impact on the Cmax of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
maximum observed plasma concentration
Evaluate the impact on the AUC0-t of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration 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;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
area under the plasma concentration-time curve from time zero to infinity
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
Evaluate the impact on the Tmax of the main metabolite 116-N1 of JT001;
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
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;
Time frame: From time zero up to 72 hours post-dose following oral administration 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;
Time frame: From time zero up to 72 hours post-dose following oral administration 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;
Time frame: From time zero up to 72 hours post-dose following oral administration 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;
Time frame: From time zero up to 72 hours post-dose following oral administration 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;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Evaluate the impact on the Ae% of the main metabolite 116-N1 of JT001;

6 secondary outcomes

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
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
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
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
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
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

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
Individual participant dataSharing planned: Undecided. Undecided

Related trials for Subjects With Renal Impairment

RecruitingPhase 1
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RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
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Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
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Active, not recruitingPhase 1/2
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
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Recruiting
SPYRAL GEMINI Pilot Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huiyu Lan, Project Director study director

Shanghai Vinnerna Biosciences Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deuremidevir Hydrobromide Tablets in people with Subjects With Renal Impairment and Healthy Subjects, run by Shanghai Vinnerna Biosciences 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 9 inclusion and 18 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 26 Sep 2023. 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?

Evaluate the impact on the Cmax of the main metabolite 116-N1 of JT001; (time frame: From time zero up to 72 hours post-dose following oral administration of JT001). The study lists 10 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 NCT05895812.

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 26 Sep 2023.