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NSCLC (advanced Non-small Cell Lung Cancer)Phase 1NCT06823258

Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function

A Phase 1 study testing HS-10365 in people with NSCLC (advanced Non-small Cell Lung Cancer), run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages. Based on the research results of moderate hepatic Impairment and matched control subjects with normal hepatic function, the sponsor will make a… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
HS-10365
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
28 Feb 2025to 31 Jul 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All participants must meet all of the following conditions:
  • Voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and be willing to strictly follow the clinical study protocol to complete this study;
  • The subjects agree to have no plans to conceive or donate sperm/eggs within 6 months from the signing of the informed consent form until the last administration, and voluntarily adopt effective contraceptive measures (non-pharmacological contraceptive measures were taken during the study period, as detailed in Appendix 1);
  • On the day of signing the informed consent form, both males and females must be at least 18 years old;
  • The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-33 kg/m2 (including both ends);
  • Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min.
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  • Subjects with normal hepatic function must also meet all of the following conditions:
  • 1) When screening, the following demographic matching criteria must be met:
  • BMI matching with the matched hepatic impairment group, with a mean within ± 15% range;
  • Age matching with the matched hepatic impairment group, with a mean of ± 5 years;
  • Gender matching with the matched hepatic impairment group，with the same number of individuals for each gender;
  • Subjects with liver dysfunction must also meet all of the following conditions:
  • Chronic liver injury caused by primary liver disease (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) in subjects with hepatic impairment classified as A or B by Child Pugh grading (see Appendix 3 for Child Pugh grading).
  • Researchers determine that the hepatic function status of the subjects has been stable for at least 2 months based on their clinical symptoms and other examination results available during screening (as determined by the researchers).
  • Individuals who have a stable medication regimen for treating hepatic impairment, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not require adjustment (including medication type, dosage, or frequency, except for diuretics, insulin, and other medications); Or those who have not taken medication.

Who cannot join

  • All participants who meet the following exclusion criteria are not eligible for this study:
  • During the screening period, 12 lead electrocardiogram results showed QT interval prolongation (male QTcF>470 ms; female QTcF>480 ms);
  • Individuals at increased risk of QT interval prolongation (such as heart failure, congenital long QT syndrome, family history of long QT syndrome, refractory hypokalemia, or unexplained sudden death in immediate family members under 40 years old);
  • Individuals who have previously suffered from cardiovascular diseases (such as organic heart disease, myocardial infarction, angina pectoris, arrhythmia, etc.) and are deemed unsuitable for inclusion by the researchers;
  • Severe or poorly controlled hypertension, including a history of hypertensive crisis or hypertensive encephalopathy; Within 2 weeks prior to the first administration, adjustments were made to antihypertensive medication due to poor blood pressure control; During the screening period, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg;
  • Those who have difficulty swallowing or have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion, and are deemed unsuitable for inclusion by the researchers;
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  • Individuals who are prone to allergic reactions or have an allergic constitution (such as those who are allergic to pollen, two or more drugs/foods), or those who are known to be allergic to the study drug or any component of the study drug;
  • Individuals who have participated in any other clinical trials within the previous 3 months and have used study drugs or plan to participate in other clinical trials during the study period (those who have not been given the study drug or placebo after enrollment may be included);
  • Individuals who have donated blood or lost blood ≥ 400 mL within the first 3 months of screening, or have received blood transfusions or used blood products, or intend to donate blood during the trial period or within 1 month after the trial ends;
  • Individuals who have used strong or moderate inducers or inhibitors of P-gp and/or CYP3A4 enzymes and/or P-gp, BCRP, MATE1 or MATE2-K substrates within the previous month of screening (see Appendix 4);
  • Prior to administration, any proton pump inhibitors (PPIs), H2 receptor antagonists, local antacids, oral alkaline drugs, or other drugs that reduce gastric acid secretion were used, and HS-10365 was administered within 7 half lives of the aforementioned drugs;
  • Individuals who have consumed a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (an average of 8 or more cups per day, 200 mL per cup) within 2 weeks prior to administration;
  • Individuals who consume grapefruit or grapefruit products within 48 hours prior to taking the investigational drug;
  • Screening for alcoholics within the first 3 months, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine) or have a positive alcohol screening result;
  • Individuals who smoke an average of 10 or more cigarettes per day within the first 3 months of screening, or who cannot stop using any tobacco products during the trial period;
  • Individuals with a history of drug use, substance abuse, or a positive urine drug test;
  • Individuals who have used vaccines or plan to use vaccines during the study period within 14 days prior to taking the investigational drug;
  • Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;
  • Difficulty in venous blood collection and/or unsuitability for receiving venipuncture / indwelling needles;
  • Due to other reasons, this study may not be completed or the researcher may determine that the participant is not suitable.
  • Subjects with normal hepatic function should be excluded if they meet any of the following exclusion criteria:
  • History of liver injury;
  • Individuals who have previously or currently suffered from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with the test results;
  • Abnormalities in physical examination, vital signs, laboratory tests, 12 lead electrocardiogram, chest X-ray, abdominal ultrasound, and other examinations have clinical significance as determined by the researchers;
  • Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody or Treponema pallidum antibody;
  • Individuals who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (excluding topical preparations that exert local effects) within 14 days prior to drug administration.
  • If a subject with hepatic impairment meets any of the following exclusion criteria, they should be excluded:
  • The subject has any of the following conditions: ① Having undergone liver transplantation in the past; ② Having undergone partial hepatectomy in the past; ③ Patients who are suspected of or diagnosed with liver cancer or other malignant tumors (except for specific cancers that have been surgically removed and completely cured, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; except for patients with liver cancer who have received radical treatment and have no recurrence; except for patients with liver cancer at BCLC stage 0)；④ Patients with liver failure; ⑤ Those who had rupture and bleeding of esophageal and gastric varices within 3 months before screening; ⑥ Patients with biliary cirrhosis, extrahepatic biliary obstruction and other diseases, and who are deemed by the investigator as not suitable to participate in this trial;
  • The laboratory test results during screening meet any of the following criteria: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>10 × ULN; (b) Absolute neutrophil count (NE #)<0.75 × 109/L; (c) Hemoglobin (HGB)<60 g/L; (d) Alpha fetoprotein (AFP)>100 ng/mL;
  • Individuals who test positive for HIV antigen/antibody screening; If the Treponema pallidum antibody is positive, the Rapid Plasma Reactive Protein (RPR) test should be added. If RPR is also positive, it should be excluded;
  • In addition to the primary liver disease itself, those who have previously or currently suffered from other serious organ systemic diseases, including but not limited to uncontrollable gastrointestinal, respiratory, renal, neurological, blood, endocrine, tumor, immune, psychiatric or cardiovascular diseases, or clinical laboratory tests that have clinical significance and have been determined by the research doctor to be unsuitable for participation in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nanya, Doctor contact

86-15804302611

wangny@jlu.edu.cn

About this study

This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages. Based on the research results of moderate hepatic Impairment and matched control subjects with normal hepatic function, the sponsor will make a comprehensive analysis to decide whether it is necessary to conduct a study on the mild hepatic Impairment and matched control subjects with normal hepatic function

Being tested
HS-10365
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • HS-10365Drug

    HS-10365 administered orally once at D1

Study groups in NCT06823258
Study groupRoleWhat they receive
Arm A: HS-10365 160mgExperimentalParticipants with Hepatic Impairment will receive HS-10365 160mg administered orally
Receives: Drug: HS-10365
Arm B: HS-10365 160mgExperimentalParticipants with normal hepatic function will receive HS-10365 160mg administered orally
Receives: Drug: HS-10365

What is being measured

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

  1. Peak plasma concentration (Cmax) of HS-10365

    Measured: From the first dose (Day 0) up to Day 6

  2. Pharmacokinetic parameters AUC0-t of HS-10365

    Measured: From the first dose (Day 0) up to Day 6

  3. Pharmacokinetic parameters AUC0-∞ of HS-10365

    Measured: From the first dose (Day 0) up to Day 6

Secondary outcomes (3)

  1. Safety : the Incidence rate of AE related to Clinical symptoms

    Measured: From the first dose (Day 0) up to Day 6

  2. Safety：the incidence rate of Laboratory ABNORMALITIES

    Measured: From the first dose (Day 0) up to Day 6

  3. the incidence rate of adverse events/serious adverse events

    Measured: From the first dose (Day 0) up to Day 6

Timeline

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

  1. First posted12 Feb 2025
  2. Study start28 Feb 2025 (estimated)
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2025 (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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06823258
Sponsor's protocol ID
HS-10365-110
Status last verified
Dec 2024
First submitted
23 Dec 2024
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10365 in people with NSCLC (advanced Non-small Cell Lung Cancer), run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

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 31 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: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Nanya, Doctor (86-15804302611, wangny@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak plasma concentration (Cmax) of HS-10365 (time frame: From the first dose (Day 0) up to Day 6). 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 NCT06823258.

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 12 Feb 2025.

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