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HyperuricemiaPhase 1NCT05954169

Pharmacokinetic/Pharmacokinetic and Safety Studies of SHR4640 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

A Phase 1 study testing SHR4640 in people with Hyperuricemia, run by Jiangsu HengRui Medicine 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
Search all trials

Trial summary

This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of SHR4640 tablets in subjects with moderate renal insufficiency and healthy subjects, and to explore the relationship between renal function (e.g., eGFR) and SHR4640 pharmacokinetic and pharmacodynamic parameters. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hyperuricemia
What is being tested?
SHR4640
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
7 Aug 2023to 1 Jul 2024
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

  • -
  • Moderate renal impaired subjects:
  • Able and willing to provide a written informed consent.
  • 18 years to 65 years (inclusive).
  • Body mass index should be between 18 and 35 kg/m2 (inclusive).
  • eGFR should be between 30 and 59 mL/min/1.73 m2 (inclusive).
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  • The renal function status is stable, and the results of two eGFR tests during the screening period (at least 3 days apart, but within 14 days) should be within ±25%.
  • If subjects with underlying diseases required drug treatment, the dose needs to be kept stable during study.
  • Healthy subjects:
  • Able and willing to provide a written informed consent.
  • 18 years to 65 years (inclusive).
  • Body mass index should be between 18 and 35 kg/m2 (inclusive).
  • eGFR should be ≥ 90 and < 130 mL/min/1.73 m2.
  • The renal function status is stable, and the results of two eGFR tests during the screening period (at least 3 days apart, but within 14 days) should be within ±25%.

Who cannot join

  • -
  • Moderate renal impaired subjects:
  • Pregnant or nursing women.
  • No birth control 2 weeks before screening or until one week after SHR4640 administration.
  • Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
  • Smokers (average daily smoking of 10 cigarettes or more in the 3 months before screening).
Show all 65Show fewer
  • Subject with a history of substance abuse and drug abuse.
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.
  • The investigators or relevant staff of the research centers or others directly involved in the study.
  • 2 weeks before SHR4640 administration sUA level ≥480 μmol/L.
  • Alanine aminotransferase and/or aspartate aminotransferase>2×ULN, alkaline phosphatase (ALP)>2.5×ULN.
  • Positive result for hepatitis B surface antigen.
  • Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody or syphilis antibody.
  • White blood cell < 3.0×109/L, and/or hemoglobin <80 g/L, and/or platelet <80×109/L.
  • 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
  • History of hypersensitivity to SHR4640 or its analogues.
  • History or suspected crystals or stones in the urinary system during the screening period of B-ultrasound.
  • History of been diagnosed with acute kidney injury in the past or screening period.
  • History of kidney transplantation.
  • Renal dialysis required during the study.
  • Urinary incontinence or anuria (eg< 100 mL/d).
  • Cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators.
  • Have grade III or IV congestive heart failure (New York Heart Association classification) or myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack within 1 year of screening, and other cardiovascular and cerebrovascular events leading to hospitalization.
  • History of active peptic ulcer within 1 year before screening, previous history of active gastrointestinal bleeding, gastrointestinal perforation, history of inflammatory bowel disease, or active peptic ulcer at screening.
  • Have a malignant tumor, or have a history of malignant tumor within 5 years before screening.
  • SBP≥180 mmHg and/or DBP ≥110 mmHg.
  • Had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study.
  • Received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 T1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device).
  • Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood ≥400 mL in the 3 months prior to screening.
  • Has unsuitable venous for blood sampling.
  • Use of any of the following, unless agreed as nonclinically relevant by the Investigator and the Sponsor:
  • 1) Use of any over the-counter, nutraceuticals, or prescription medications that might interfere with the absorption, distribution, metabolism, or excretion of SHR4640 (proton-pump inhibitor, fluconazole, indomethacin, ranitidine, flurbiprofen, probenecid, aprepitant, etc.) within 2 weeks of screening.
  • 2) Unstable dosage of urate-lowering drugs within 6 weeks of Day 1. 3) Diuretics within 2 weeks of Day 1. 4) Aspirin in excess of 100 mg daily or unstable dose within the 2 weeks of Day 1.
  • 5) Unstable dosage of antihypertensive, lipid-lowering and hypoglycemic drugs within 2 weeks of Day 1.
  • 6) Have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to Day 1, or who plan to receive live vaccines or live attenuated vaccines during the study.
  • 30. Consumes grapefruit and/or poppy seed within 48 hours before SHR4640 administration.
  • 31. Taken prescription drugs, over-the-counter drugs, herbal medicines or food supplements other than drugs for the treatment of renal insufficiency and other concomitant diseases within 2 weeks before Day 1.
  • Healthy subjects:
  • Pregnant or nursing women.
  • No birth control 2 weeks before screening or until one week after SHR4640 administration.
  • Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
  • Smokers (average daily smoking of 10 cigarettes or more in the 3 months before screening).
  • Subject with a history of substance abuse and drug abuse.
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.
  • The investigators or relevant staff of the research centers or others directly involved in the study.
  • 2 weeks before SHR4640 administration sUA level ≥420 μmol/L.
  • Laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) during the screening period were abnormal and the investigators determined that they were clinically significant.
  • Positive result for hepatitis B surface antigen.
  • Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody or syphilis antibody.
  • 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
  • History of hypersensitivity to SHR4640 or its analogues.
  • History or suspected crystals or stones in the urinary system during the screening period of B-ultrasound.
  • History of been diagnosed with chronic or acute kidney injury in the past or screening period. History of kidney transplantation.
  • Cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators.
  • Have a malignant tumor, or have a history of malignant tumor within 5 years before screening.
  • SBP>140 mmHg or <90 mmHg and/or DBP >90 mmHg or <60 mmHg.
  • Had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study.
  • Received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 T1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device).
  • Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood ≥400 mL in the 3 months prior to screening.
  • Has unsuitable venous for blood sampling.
  • Use of any of the following, unless agreed as nonclinically relevant by the Investigator and the Sponsor:
  • 1) Use of any over the-counter, nutraceuticals, or prescription medications that might interfere with the absorption, distribution, metabolism, or excretion of SHR4640 (proton-pump inhibitor, fluconazole, indomethacin, ranitidine, flurbiprofen, probenecid, aprepitant, etc.) within 2 weeks of screening.
  • 2) Use of urate-lowering drugs within 6 weeks of Day 1. 3) Have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to Day 1, or who plan to receive live vaccines or live attenuated vaccines during the study.
  • 24. Consumes grapefruit and/or poppy seed within 48 hours before SHR4640 administration.
  • 25. Taken any prescription drugs, over-the-counter drugs, herbal medicines or food supplements within 2 weeks before Day 1.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 511447

Other trials in China

About this study

Official title: A Single-dose, Open-label/Pharmacokinetic and Safety Study of SHR4640 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of SHR4640 tablets in subjects with moderate renal insufficiency and healthy subjects, and to explore the relationship between renal function (e.g., eGFR) and SHR4640 pharmacokinetic and pharmacodynamic parameters.

Conditions
Hyperuricemia
Being tested
SHR4640
Medical subject headings
Hyperuricemia

What participants receive

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

  • SHR4640Drug

    SHR4640 single-dose

Study groups in NCT05954169
Study groupRoleWhat they receive
Treatment group A in moderately renal insufficiency subjectsExperimentalNot described
Receives: Drug: SHR4640
Treatment group B in healthy subjectsExperimentalNot described
Receives: Drug: SHR4640

What is being measured

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

  1. PK parameters of SHR4640: Cmax

    Measured: 0 hour to 72 hour after administration

  2. PK parameters of SHR4640: AUC0-t

    Measured: 0 hour to 72 hour after administration

  3. PK parameters of SHR4640: AUC0-inf

    Measured: 0 hour to 72 hour after administration

Secondary outcomes (8)

  1. PK parameters of SHR4640: Tmax

    Measured: 0 hour to 72 hour after administration

  2. PK parameters of SHR4640: t1/2

    Measured: 0 hour to 72 hour after administration

  3. PK parameters of SHR4640: CL/F

    Measured: 0 hour to 72 hour after administration

  4. PK parameters of SHR4640: Vz/F

    Measured: 0 hour to 72 hour after administration

  5. Amount of SHR4640 excreted in urine (Ae0-72h)

    Measured: 0 hour to 72 hour after administration

  6. Serum uric acid concentration

    Measured: 0 hour to 72 hour after administration

  7. Amount of uric acid excreted in urine

    Measured: 0 hour to 72 hour after administration

  8. Adverse events

    Measured: from ICF signing date to approximate day 8

Timeline

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

  1. First posted20 Jul 2023
  2. Study start7 Aug 2023
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Single-dose, open
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05954169
Sponsor's protocol ID
SHR4640-111
Status last verified
Jul 2024
First submitted
13 Jul 2023
Last updated
11 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR4640 in people with Hyperuricemia, run by Jiangsu HengRui Medicine 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 14 inclusion and 65 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 11 Jul 2024. 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?

PK parameters of SHR4640: Cmax (time frame: 0 hour to 72 hour after administration). The study lists 3 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 NCT05954169.

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 11 Jul 2024.

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