Study of SHR6390 in Renal Insufficiency and Healthy Subjects

NCT05515289 | Unknown Phase 1

• 1 other identifier: SHR6390-I-114
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• 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

• 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

Study Arms (3)

Treatment group: mild renal insufficiency

EXPERIMENTAL

Drug: SHR6390

Treatment group: moderate renal insufficiency

EXPERIMENTAL

Drug: SHR6390

Treatment group: healthy subjects

EXPERIMENTAL

Drug: SHR6390

Interventions

SHR6390 DRUG

SHR6390 tablet single dose, and subjects will take the SHR6390 on Day 1.

Also known as: dalpiciclib

Treatment group: healthy subjects; Treatment group: mild renal insufficiency; Treatment group: moderate renal insufficiency

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subjects with renal insufficiency
• Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test;
• Age 18 to 70 years old, gender is not limited;
• Body mass index (BMI) in the range of 19 kg/m2 to 28 kg/m2 (including both ends);
• Renal function index (expressed in GFR, by the MDRD formula (refer to Appendix I) meets the following criteria: Subjects with mild renal insufficiency (stage CKD2): 60-89 mL/min (both ends included)；Subjects with moderate renal insufficiency (stage CKD3): 30-59 mL/min (both ends included)；
• The renal function state is stable, and the GFR results of the two tests before administration (the interval between the two tests should be at least 3 days) should be within the same CKD segmentation period;
• Fertile female subjects must undergo a pregnancy test before administration and the result is negative; must be non-lactating; Female subjects with fertility who used medically approved, highly effective contraception for 7 months from the signing of informed consent to the last dose; Male subjects whose partners are fertile women, who use medically approved, highly effective contraception for 4 months after the last dose; There are no sperm donations, egg donations and fertility plans.
• Healthy subjects
• Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test;
• Age 18 to 70 years old, gender is not limited;
• Body mass index (BMI) in the range of 19 kg/m2 to 28 kg/m2 (including both ends);
• Renal function index (expressed in GFR, calculated as above) ≥ 90 mL/min and \< 130 mL/min;
• Comprehensive vital signs examination, physical examination, routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function, etc.), 12-lead ELECTROCardiogram, X-chest x-ray or chest CT, abdominal ultrasound and other examinations have been judged by the researchers to be normal or abnormal and have no clinical significance;
• The principle of gender ratio matching in the health group: try to match the sex ratio of men and women in the renal insufficiency group; The age matching principle is: ± 10 years old; The fasting weight matching principle is: ± 10 kg;
• Fertile female subjects must undergo a pregnancy test before administration and the result is negative; must be non-lactating; Female subjects with fertility who used medically approved, highly effective contraception for 7 months from the signing of informed consent to the last dose; Male subjects whose partners are fertile women, who use medically approved, highly effective contraception for 4 months after the last dose; There are no sperm donations, egg donations and fertility plans. (Refer to Appendix II).

You may not qualify if:

• \- 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):
• Neutrophil absolute values \< 1.5×109/L；
• Absolute lymphocyte value \< 0.8×109/L ;
• Platelet count \<150×109/L；
• Total bilirubin \> 1.5 × ULN;
• ALT and AST\>2×ULN;
• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongda Hospital Southesat University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dalpiciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

YIKE WANG

CONTACT

+86-134-0862-8814; yike.wang@hengrui.com

Lude Tang

CONTACT

+86-18036617805; lude.tang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a single-center, open, single-dose, self-controlled clinical trial.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 25, 2022
• Study Start: December 18, 2022
• Primary Completion: August 28, 2023
• Study Completion: September 28, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

CN (1)