Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal… (NCT06671444) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment
China16 participantsStarted 2024-06-03
Plain-language summary
Objective：
1. To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
2. To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
Who can participate
Age range
18 Years – 65 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.
Exclusion criteria
. Allergic constitution, such as those with a known history of allergies to drugs, food or other substances, or those with a history of allergies to YZJ-1139 tablets or similar orexin receptor antagonist drugs and excipients;
. Subjects with difficulty swallowing tablets, and special dietary requirements who cannot accept a unified diet;
. Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting;
. Subjects who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the study;
. 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;
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
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of YZJ-1139
Timeframe: From Day 1 to Day 3
2
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139
Timeframe: From Day 1 to Day 3
3
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
Timeframe: From Day 1 to Day 3
4
Apparent Oral Clearance (CL/F) of Entrectinib
Timeframe: From Day 1 to Day 3
5
The Apparent Volume of Distribution (Vz/F) of Entrectinib
Timeframe: From Day 1 to Day 3
6
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
Timeframe: From Day 1 to Day 3
7
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
. Patients who have received kidney transplantation and/or require renal dialysis during the trial.
. Except for the disease causing renal dysfunction itself, those who have previously or currently suffered from other serious systemic organ diseases, including respiratory, digestive, endocrine, malignant tumor, blood, mental/nervous system serious diseases, which were judged by the investigator to be unsuitable for participation in this trial;
. Subjects with ALT and/or AST \> 2 ULN and/or TBIL \> 1.5 ULN, Hb \< 80 g/L, QTcF \> 450 ms in males and QTcF \> 470 ms in females by ECG.
8
Mean Residence Time (MRT0-t) of YZJ-1139
Timeframe: From Day 1 to Day 3
9
Renal Excretion (Ae) of YZJ-1139
Timeframe: From Day 1 to Day 3
10
renal clearance (CLR) of YZJ-1139
Timeframe: From Day 1 to Day 3
11
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)