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Gout and HyperuricemiaPhase 1NCT06196580

PK Effects of SHR4640 on Repaglinide and Midazolam, and the Impact of SHR4640 on QT Interval

A Phase 1 study testing repaglinide; midazolam; SHR4640 in people with Gout and 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
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Trial summary

The purpose of this study is to evaluate the PK effects of SHR4640 tablets on repaglinide and midazolam, as well as the effects of SHR4640 tablets on the QT interval in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Gout and Hyperuricemia
What is being tested?
repaglinide; midazolam; SHR4640
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteChina
Study dates
4 Jan 2024to 16 Feb 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Voluntarily sign the informed consent form before the start of the trial-related activities, and be able to understand the procedures and methods of the trial, and are willing to strictly comply with the clinical trial protocol to complete the trial;
  • Aged 18 to 45 years old (both ends included, subject to the time of signing the informed consent form), male or female;
  • Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2 (both ends included);
  • No fertility plan and agree to take non-drug high-efficiency contraceptive measures (see appendix 1 for details) within 28 days from signing the informed consent form to the last administration of the trial drug, and no plans for sperm donation or egg donation.

Who cannot join

  • Individuals who have a history of smoking within the 3 months before signing the informed consent form (average daily smoking>5 cigarettes) or who cannot stop using any tobacco products during the study period;
  • The average daily intake of alcohol in the three months before signing the informed consent is more than 7 g for women (about 200 ml beer, 70 ml wine or 22 ml low-alcohol liquor) and 14 g for men (about 400 ml beer, 140 ml wine or 45 ml low-alcohol liquor); Those who cannot abstain from alcohol during the trial;
  • Within the first 7 days of randomization, consumed any beverage or food containing grapefruit; Or have eaten any beverages or foods containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within the previous 2 days at random;
  • Allergic constitution, or allergic or suspected allergic to SHR4640 tablets, repaglinide or midazolam;
  • Drug abusers, or those who have positive urinary abuse during screening;
  • any history of severe clinical disease or conditions that the researcher believes may affect the results of the trial, including but not limited to the history of circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, and metabolic diseases;
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  • Patients with contraindication of repaglinide (type 1 diabetes, C-peptide negative diabetes patients, diabetes ketoacidosis patients with or without coma);
  • Patients with contraindications to midazolam (acute angle closure glaucoma, severe respiratory insufficiency, sleep apnea syndrome, myasthenia gravis, schizophrenia, and severe depressive state);
  • During screening, vital signs, physical examinations, laboratory tests, cardiac ultrasound, abdominal ultrasound, or chest imaging examinations indicate the presence of abnormalities that are clinically significant according to the judgment of the investigator;
  • When screening, ultrasound examination of the urinary system indicates the presence of stones or crystals in the urinary system;
  • Individuals with acute kidney injury before screening or random ;
  • Individuals with serum uric acid higher than 420 μmol/L at screening, , or a history of hyperuricemia and/or gout disease;
  • Individuals with QTcF>450 ms, PR interval>200 ms, QRS complex time limit>120 ms, or HR>100 bpm, or other abnormalities that were clinically significant as determined by the researcher;
  • Individuals with risk factors for torsade de pointe ventricular tachycardia, such as heart failure, hypokalemia, short QT syndrome, long QT syndrome, or a first-degree relatives family history of unexplained sudden death, drowning, or sudden infant death syndrome in young adulthood (≤ 40 years old);
  • Individuals with positive hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies, or syphilis antibodies during screening;
  • Individuals who have used any prescription drugs, over-the-counter drugs, herbal medicines, or dietary supplements within two weeks before randomization;
  • Systemic treatment with cytochrome P450 3A4 enzyme (CYP3A4), CYP2C8 inhibitor or inducer drugs used within the first 4 weeks of randomization ;
  • Individuals (excluding screening failures) who have participated in any other drug or medical device clinical trials within 3 months before randomization or within 5 half-lives of the trial drug (whichever is longer);
  • Individuals who have undergone any surgery within three months before randomization, or have not recovered after surgery, or plan to undergo surgery during the trial;
  • Individuals who have donated (or lost) blood within three months before randomization and the amount of blood donated (or lost) is ≥400 mL, or received blood transfusion;
  • According to the judgment of the researchers, subjects with conditions that affect drug absorption, distribution, metabolism, and excretion, or other factors that are not suitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 300041

Other trials in China

About this study

Official title: A Clinical Study Evaluating the Pharmacokinetic Effects of SHR4640 on Repaglinide and Midazolam in Healthy Subjects and the Impact of SHR4640 on QT Interval

The purpose of this study is to evaluate the PK effects of SHR4640 tablets on repaglinide and midazolam, as well as the effects of SHR4640 tablets on the QT interval in healthy subjects.

Being tested
repaglinide; midazolam; SHR4640, repaglinide; midazolam; SHR4640; SHR4640 placebo, repaglinide; midazolam; SHR4640 placebo
Medical subject headings
Gout, Hyperuricemia

What participants receive

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

  • repaglinide; midazolam; SHR4640Drug

    repaglinide; midazolam; SHR4640

  • repaglinide; midazolam; SHR4640; SHR4640 placeboDrug

    repaglinide; midazolam; SHR4640; SHR4640 placebo

  • repaglinide; midazolam; SHR4640 placeboDrug

    repaglinide; midazolam; SHR4640 placebo

Study groups in NCT06196580
Study groupRoleWhat they receive
SHR4640 group AExperimentalNot described
Receives: Drug: repaglinide; midazolam; SHR4640
SHR4640 group BExperimentalNot described
Receives: Drug: repaglinide; midazolam; SHR4640; SHR4640 placebo
SHR4640 PlaceboPlacebo comparatorNot described
Receives: Drug: repaglinide; midazolam; SHR4640 placebo

What is being measured

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

  1. The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: Cmax

    Measured: Day 1 to Day 24

  2. The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: AUC0-t

    Measured: Day 1 to Day 24

  3. The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: AUC0-inf

    Measured: Day 1 to Day 24

  4. QTcF corrected for baseline and placebo after oral administration of SHR4640 tablets（ ΔΔ QTcF）

    Measured: Day 1 to Day 24

Secondary outcomes (8)

  1. The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: Tmax

    Measured: Day 1 to Day 24

  2. The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: t1/2

    Measured: Day 1 to Day 24

  3. The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: CL/F

    Measured: Day 1 to Day 24

  4. The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: Vz/F

    Measured: Day 1 to Day 24

  5. PK parameters for oral SHR4640 tablets: Cmax

    Measured: Day 1 to Day 24

  6. PK parameters for oral SHR4640 tablets: AUC0-t

    Measured: Day 1 to Day 24

  7. PK parameters for oral SHR4640 tablets: Tmax

    Measured: Day 1 to Day 24

  8. Safety indicators: adverse events

    Measured: Screening period up to Day 28

Timeline

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

  1. First posted9 Jan 2024
  2. Study start4 Jan 2024
  3. Primary completion16 Feb 2024
  4. Study completion16 Feb 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
Randomised
Intervention model
Parallel groups
Model description
This study is a single-center, randomized, double blind, three-period, and three-group parallel design trial, consisting of three groups (group A、 group B and placebo group).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196580
Sponsor's protocol ID
SHR4640-113
Status last verified
Mar 2024
First submitted
24 Dec 2023
Last updated
6 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cheng Y, Hu X, Pei Z, Zhang Z, Lin H, Feng S, Gao Z, Ma Y, Cao Z, Zhang Q, Zheng L, Zhang W, Shen K, Hu W. Evaluating the drug-drug interactions of SHR4640 on repaglinide and midazolam in healthy subjects. Expert Opin Drug Metab Toxicol. 2025 Jan-Feb;21(2):217-224. doi: 10.1080/17425255.2024.2428367. Epub 2024 Nov 14.

    PubMed 39530130

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing repaglinide; midazolam; SHR4640 in people with Gout and 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 4 inclusion and 21 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 6 Mar 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. Some participants in this study may receive a placebo. 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?

The plasma PK parameters of repaglinide, midazolam, and SHR4640 in combination: Cmax (time frame: Day 1 to Day 24). The study lists 4 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 NCT06196580, which also lists 1 linked publication.

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 6 Mar 2024.

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