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The study is a single-center, open, single-dose, self-controlled clinical trial. It is planned to enroll 24-30 subjects.
Subjects will take the SHR6390 on Day1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group: mild renal insufficiency | Experimental |
| |
| Treatment group: moderate renal insufficiency | Experimental |
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| Treatment group: healthy subjects | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390 | Drug | SHR6390 tablet single dose, and subjects will take the SHR6390 on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dalpiciclib main pharmacokinetic parameters: Cmax | from Day 1 to Day 10 | |
| Dalpiciclib main pharmacokinetic parameters: AUC0-t | from Day 1 to Day 10 | |
| Dalpiciclib main pharmacokinetic parameters: AUC0-∞ | from Day 1 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary pharmacokinetic parameters of Dalpiciclib: Tmax | from Day 1 to Day 10 | |
| Secondary pharmacokinetic parameters of Dalpiciclib: t1/2 | from Day 1 to Day 10 | |
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Inclusion Criteria:
- Subjects with renal insufficiency
Healthy subjects
Exclusion Criteria:
- Subjects with renal insufficiency
Have had a kidney transplant;
Renal dialysis is required during the study;
Urinary incontinence or anuresis;
People who are allergic to research drugs or excipients;
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, arrhythmia, myocardial infarction, QTcF≥470 ms (female) or 450 ms (male), etc.;
Coagulation dysfunction (INR>1.5) or prothrombin time (PT) >ULN + 4 seconds or APTT >1.5 ×ULN), or clinically significant bleeding symptoms or clear bleeding tendencies within 3 months before screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., or receiving thrombolytic anticoagulation;
Laboratory tests such as blood routine and blood biochemistry show that the functional level of the organ meets the following abnormalities (no blood transfusion or hematopoietic growth factor therapy is received within 2 weeks before the blood routine screening):
Patients with hypertension who cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg);
Liver diseases that affect metabolism or digestive tract diseases that affect absorption;
Those who donated 400 mL of blood ≥ in the 3 months before screening, or 200 mL ≥ 1 month before screening, or who received blood transfusions;
Screening of those who have used any clinical trial drugs in the previous 3 months;
Drugs that induce CYP3A, CYP2C8, CYP2C9 enzymes were used 28 days before taking the study drug, and drugs with inhibitory effects on CYP3A, CYP2C8, CYP2C9 enzymes were used 14 days before taking the study drug, or needed to be used during the trial, any drug that affects the metabolic enzymes CYP3A, CYP2C8, CYP2C9; or use any Chinese medicine or proprietary Chinese medicine 7 days before taking the research drug;
Alcoholics (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine; 5 cigarettes smoked per day≥), or those who could not smoke and abstain from alcohol during the trial period, or those who screened positive for alcohol;
Those who have a positive urine drug abuse screening, or those who have a history of drug abuse in the past five years or who have used drugs in the 3 months before the test;
Active HBV infection (gene copy number test for HBsAg positive), or positive for HCV and syphilis antibodies;
Have a history of immunodeficiency (including HIV test-positive, other acquired, congenital immunodeficiency diseases) or organ transplantation;
48 hours before taking the study drug until the end of the study, subjects refused to stop any beverage containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or grapefruit (grapefruit) or grapefruit and products containing grapefruit or grapefruit ingredients (grapefruit juice, grapefruit juice, etc.);
48 hours before taking the drug until the end of the study, the subject exercised vigorously, or had other factors affecting the absorption, distribution, metabolism and excretion of the drug;
Those who were vaccinated live within 2 weeks prior to the first use of the study drug, or who planned to receive live vaccination within 7 days of the end of the study
Subjects who the investigator believes have other factors that are not suitable for participating in this test.
Healthy subjects
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YIKE WANG | Contact | +86-134-0862-8814 | yike.wang@hengrui.com | |
| Lude Tang | Contact | +86-18036617805 | lude.tang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Southesat University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000720752 | dalpiciclib |
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The study is a single-center, open, single-dose, self-controlled clinical trial.
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| Secondary pharmacokinetic parameters of Dalpiciclib: CL/F |
| from Day 1 to Day 10 |
| Secondary pharmacokinetic parameters of Dalpiciclib: Vz/F | from Day 1 to Day 10 |
| Secondary pharmacokinetic parameters of Dalpiciclib: CLR | from Day 1 to Day 10 |
| Secondary pharmacokinetic parameters of Dalpiciclib: Ae | from Day 1 to Day 10 |
| Secondary pharmacokinetic parameters of Dalpiciclib: Ae% | from Day 1 to Day 10 |
| Incidence and severity of good/serious adverse events (rated based on CTCAE v5.0) | from Day1 to Day19,an average of 1 month |
| D017437 |
| Skin and Connective Tissue Diseases |