Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic … (NCT06671509) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment
China24 participantsStarted 2024-03-22
Plain-language summary
Primary Objectives:
To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139
Secondary Objectives:
To evaluate the safety of a single oral dose of YZJ-1139 in subjects with mild, moderate and normal hepatic impairment
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign an informed consent form before the start of activities related to this trial, and be able to understand the procedures and methods of this trial, willing to strictly follow the clinical trial protocol to complete this trial;
. The subjects (including partners) are willing to self screen and have no family planning within 3 months after the administration of the investigational drug, and voluntarily take contraceptive measures (see Appendix 1 for specific contraceptive measures);
. On the day of signing the informed consent form, the age range is 18 to 70 years old (including both ends), both men and women are eligible;
. 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) 18-32 kg/m2 (including both ends);
. Creatinine clearance rate (calculated using Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
Timeframe: From Day 1 to Day 3
2
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of YZJ-1139
Timeframe: From Day 1 to Day 3
3
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of YZJ-1139
Timeframe: From Day 1 to Day 3
4
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
Timeframe: From Day 1 to Day 3
5
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
Timeframe: From Day 1 to Day 3
6
Apparent Oral Clearance (CL/F) of Entrectinib
Timeframe: From Day 1 to Day 3
7
The Apparent Volume of Distribution (Vz/F) of Entrectinib
. Chronic liver injury caused by primary liver diseases (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) or clinically diagnosed as cirrhosis (see Appendix 3 for diagnostic criteria for cirrhosis), and liver dysfunction patients with Child Pugh grading of A or B (see Appendix 4 for Child Pugh grading).
. Individuals who have a stable medication regimen for the treatment of liver dysfunction, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not need to be adjusted (including medication type, dosage, or frequency); Or those who have not taken medication;
. The demographic mean of subjects in the normal liver function group (Group C) during screening must meet the following matching criteria:
Exclusion criteria
. Allergic constitution, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those with a history of allergies to experimental drugs or similar drugs or excipients;
. Screening period electrocardiogram showed QTc interval (QTcF)\>470 msec in males and\>480 msec in females (corrected according to Fridericia's standard: QTcF=QT/(RR \^ 0.33), RR=60/heart rate);
. Screening for individuals who have had severe infections, trauma, gastrointestinal surgery, or other surgical procedures within the first 4 weeks;
. Individuals with a history of paroxysmal sleep disorder, obstructive sleep apnea, complex sleep behavior (such as dream walking, driving in dreams, etc.), severe unconscious hypoglycemia, stroke, epilepsy, and other psychiatric disorders (including anxiety, depression, etc.), convulsive diseases, and sudden onset of illness;
. Individuals who have donated blood or lost ≥ 200 mL of blood within the first 3 months of screening, received blood transfusions or used blood products, or planned to donate blood during the trial period or within 1 month after the end of the trial;
. Individuals who have used CYP3A4 enzyme inducers or inhibitors within one month prior to administration (or five half-lives, whichever is longer) (see Appendix 5);
. 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, 200mL per cup) within 2 weeks prior to administration;
. Screening for alcoholics within the first three months, i.e. those who consume more than 14 units of alcohol per week (1 unit ≈ 360 mL of beer, or 45 mL of 40% spirits, or 150 mL of wine) or those who have tested positive for alcohol screening; Screening for individuals who smoke an average of 10 or more cigarettes per day within the first 3 months;