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

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

NCT06196580•Jiangsu HengRui Medicine Co., Ltd.

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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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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;
•2. Aged 18 to 45 years old (both ends included, subject to the time of signing the informed consent form), male or female;
•3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2 (both ends included);
•4. 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.

Exclusion Criteria

•1. 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;
•2. 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;
•3. 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;
•4. Allergic constitution, or allergic or suspected allergic to SHR4640 tablets, repaglinide or midazolam;
•5. Drug abusers, or those who have positive urinary abuse during screening;
•6. 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;
•7. Patients with contraindication of repaglinide (type 1 diabetes, C-peptide negative diabetes patients, diabetes ketoacidosis patients with or without coma);
•8. Patients with contraindications to midazolam (acute angle closure glaucoma, severe respiratory insufficiency, sleep apnea syndrome, myasthenia gravis, schizophrenia, and severe depressive state);
•9. 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;
•10. When screening, ultrasound examination of the urinary system indicates the presence of stones or crystals in the urinary system;
+11 more criteria

Locations (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Key Dates

Start Date

January 4, 2024

Primary Completion Date

February 16, 2024

Completion Date

February 16, 2024

Last Updated

March 6, 2024

Enrollment

ACTUAL participants

Conditions

Gout and Hyperuricemia

Interventions

repaglinide; midazolam; SHR4640

DRUG

repaglinide; midazolam; SHR4640; SHR4640 placebo

DRUG

repaglinide; midazolam; SHR4640 placebo

DRUG

Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

NCT02078219

Gout and Hyperuricemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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