A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxala… (NCT06680531) | Clinical Trial Compass
CompletedPhase 1
A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets
China24 participantsStarted 2024-08-31
Plain-language summary
Primary Objective:
1\) To evaluate the pharmacodynamic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; 2) To evaluate the pharmacokinetic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; To observe the safety of YZJ-1139 tablets taken together with Escitalopram oxalate tablets.
Who can participate
Age range
18 Years – 45 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
. Male or female subjects aged 18 to 45 years (inclusive);
. Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 \~ 28.0 kg/m2 (inclusive);
. Subjects with normal physical examination, vital signs, 12-lead ECG and laboratory tests results or abnormal but no clinical significance;
. Subjects who are in good health and have no history of serious or chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system;
. Subjects of childbearing potential (including partners) have no family planning or donate sperm/eggs from 2 weeks before screening to 3 months after dosing, and voluntarily take appropriate contraceptive measures;
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
saccade eye movement test
Timeframe: From Day 1 to Day 11
2
body swing test
Timeframe: From Day 1 to Day 11
3
selective reaction time test
Timeframe: From Day 1 to Day 11
4
number symbol conversion test
Timeframe: From Day 1 to Day 11
5
word memory test
Timeframe: From Day 1 to Day 11
6
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
Timeframe: From Day 1 to Day 11
7
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 11
8
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139
. Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
Exclusion criteria
. Allergic constitution, such as those with a known history of allergies to two or more drugs or foods, or those with a history of allergies to experimental drugs or 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;
. Known to have QT prolongation or congenital QT syndrome or screening period electrocardiogram showed QTc interval (QTcF)\>450 msec in males and\>470 msec in females(QTcF= QT/(RR\^0.33));
. Those who are positive in any index screening of hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum-specific antibody, and human immunodeficiency virus antibody;
. Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening;
Timeframe: From Day 1 to Day 11
9
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
Timeframe: From Day 1 to Day 11
10
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
Timeframe: From Day 1 to Day 11
11
Apparent Oral Clearance (CL/F) of Entrectinib
Timeframe: From Day 1 to Day 11
12
The Apparent Volume of Distribution (Vz/F) of Entrectinib
Timeframe: From Day 1 to Day 11
13
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)