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Breast CancerPhase 1NCT05515289

Study of SHR6390 in Renal Insufficiency and Healthy Subjects

A Phase 1 study testing SHR6390 in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
SHR6390
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
18 Dec 2022to 28 Sep 2023
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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.;
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  • 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;
  • 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
  • Have had a kidney transplant;
  • People who are allergic to research drugs or excipients;
  • Clinically significant heart disease within 12 months before 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 such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc., within 3 months before screening, or receiving thrombolytic anticoagulation;
  • There is a clear medical history of primary diseases of important organs such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and skeletal musculoskeletal system, etc., and the researchers believe that they are not suitable for participating in this study;
  • Those who donated 400 mL of blood ≥ 3 months before screening, or 200 mL of blood donated in≥ 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 research drug, and drugs with inhibitory effect on CYP3A, CYP2C8, CYP2C9 enzymes were used 14 days before taking the research 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;
  • Urine drug abuse screening positive, or those who have a history of drug abuse in the past five years or have used drugs in the 3 months before the test;
  • Positive HBsAg, HCV or syphilis antibody test;
  • 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, the subject 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 be vaccinated within 7 days of the end of the study
  • Inability to receive a uniform diet and inability to tolerate indwelling needles for intravenous blood collection;
  • Subjects who the investigator believes have other factors that are not suitable for participating in this test.

Trial locations and contacts

1 site in 1 country.

YIKE WANG contact

+86-134-0862-8814

yike.wang@hengrui.com

Lude Tang contact

+86-18036617805

lude.tang@hengrui.com

China1 site, 1 recruiting

  • Zhongda Hospital Southesat University

    Nanjing, Jiangsu, 210009

    Bicheng Liu, Doctor, 025-83262422, liubc64@163.com

    Recruiting

Other trials in China

About this study

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
Being tested
SHR6390
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SHR6390Drug

    Also called dalpiciclib

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

Study groups in NCT05515289
Study groupRoleWhat they receive
Treatment group: mild renal insufficiencyExperimentalNot described
Receives: Drug: SHR6390
Treatment group: moderate renal insufficiencyExperimentalNot described
Receives: Drug: SHR6390
Treatment group: healthy subjectsExperimentalNot described
Receives: Drug: SHR6390

What is being measured

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

  1. Dalpiciclib main pharmacokinetic parameters: Cmax

    Measured: from Day 1 to Day 10

  2. Dalpiciclib main pharmacokinetic parameters: AUC0-t

    Measured: from Day 1 to Day 10

  3. Dalpiciclib main pharmacokinetic parameters: AUC0-∞

    Measured: from Day 1 to Day 10

Secondary outcomes (8)

  1. Secondary pharmacokinetic parameters of Dalpiciclib: Tmax

    Measured: from Day 1 to Day 10

  2. Secondary pharmacokinetic parameters of Dalpiciclib: t1/2

    Measured: from Day 1 to Day 10

  3. Secondary pharmacokinetic parameters of Dalpiciclib: CL/F

    Measured: from Day 1 to Day 10

  4. Secondary pharmacokinetic parameters of Dalpiciclib: Vz/F

    Measured: from Day 1 to Day 10

  5. Secondary pharmacokinetic parameters of Dalpiciclib: CLR

    Measured: from Day 1 to Day 10

  6. Secondary pharmacokinetic parameters of Dalpiciclib: Ae

    Measured: from Day 1 to Day 10

  7. Secondary pharmacokinetic parameters of Dalpiciclib: Ae%

    Measured: from Day 1 to Day 10

  8. Incidence and severity of good/serious adverse events (rated based on CTCAE v5.0)

    Measured: from Day1 to Day19，an average of 1 month

Timeline

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

  1. First posted25 Aug 2022
  2. Study start18 Dec 2022
  3. Primary completion28 Aug 2023 (estimated)
  4. Study completion28 Sep 2023 (estimated)

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study is a single-center, open, single-dose, self-controlled clinical trial.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05515289
Sponsor's protocol ID
SHR6390-I-114
Status last verified
Mar 2023
First submitted
22 Aug 2022
Last updated
10 Mar 2023
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 SHR6390 in people with Breast Cancer, 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 15 inclusion and 44 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact YIKE WANG (+86-134-0862-8814, yike.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dalpiciclib main pharmacokinetic parameters: Cmax (time frame: from Day 1 to Day 10). 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 NCT05515289.

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 10 Mar 2023.

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