The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexp… (NCT06674694) | Clinical Trial Compass
RecruitingPhase 1
The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.
China56 participantsStarted 2024-04-10
Plain-language summary
Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.
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.
Inclusion criteria
. Male and female subjects aged 18 to 65 years (including) at the time of signing the informed consent (the number of single sex in each group is not less than 1/4);
. Body mass index (BMI) in the range of 19.0-26.0 (including the critical value), and female weight ≥ 45 kg, male weight ≥ 50 kg;
. Subjects of childbearing potential (including partners) have no pregnancy plan or sperm donation and egg donation plan since signing the informed consent form to within 1 year after the last dose of the investigational drug, and voluntarily take effective contraceptive measures;
. Sign informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
. Subjects can communicate well with the investigator, and understand and comply with the requirements of this study.
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
Number of reported Adverse Events (AE)
Timeframe: Collected from signing of informed consent until 90 days after a single dose.
2
Clinical Laboratory Tests
Timeframe: Collected from signing of informed consent until 90 days after a single dose.
3
Change in physical exam results
Timeframe: Collected from signing of informed consent until 90 days after a single dose.
4
Vital signs
Timeframe: Collected from signing of informed consent until 90 days after a single dose.
5
ECG Reading
Timeframe: Collected from signing of informed consent until 90 days after a single dose.
6
Extrapyramidal Symptoms (EPS) Rating Scale
Timeframe: Collected from signing of informed consent until 90 days after a single dose.
7
Change in Suicidality via Columbia-Suicide Severity Rating Scale
Timeframe: Collected from signing of informed consent until 90 days after a single dose.
. Male and female subjects aged 18 to 65 years (including) at the time of signing the informed consent (the number of single sex in each group is not less than 1/4);
. Patients diagnosed with schizophrenia according to ICD-10, and the positive and negative symptom scale (PANSS) score ≤ 70 points, and the investigator judged stable disease within 4 weeks before screening;
. Body mass index (BMI) ≥ 18.5 kg/m2 and \< 35.0 kg/m2, and female weight ≥ 45 kg, male weight ≥ 50 kg;
Exclusion criteria
. History of cardiovascular system (such as history of ischemic heart disease), endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities, and the researchers believe that there is still clinical significance;
. Physical examination, vital signs, 12-lead electrocardiogram, clinical laboratory tests (including hematology, urinalysis, serum biochemistry, thyroid panel, coagulation panel, serum prolactin, virological examination, lipid panel, serum pregnancy test (only women of childbearing age) and glycosylated hemoglobin, etc.), chest X-ray or CT and B-ultrasound with Injection site results in injection site are abnormal and clinically significant;;
. Those who have taken any brexpiprazole preparation within 28 days prior to oral tolerance test drugs (brexpiprazole tablets);
. Those who have been enrolled in clinical trials of brepiprazole long-acting injection and have received the test drug administration;
. Participate in any drug or medical device clinical trial and receive the treatment of the investigational drug or medical device within 28 days before dosing (other than the drug/equipment used in this study), except for subjects participating in the research or observational study;
. Those who have used any drugs that interact with brepiprazole within 30 days before administration \[including CYP3A4 inducers and inhibitors, CYP2D6 inducers and inhibitors\] (except topical preparations with local effects);
. Those who have used any drugs within 14 days before administration \[including prescription drugs, over-the-counter drugs, traditional Chinese medicine, etc.\] (except topical preparations with local effects);
. Consumption of foods or beverages rich in xanthine (such as sardines, animal liver, etc.), grapefruit (such as grapefruit, western grapefruit, lime, carambola, etc.), caffeine (such as coffee, strong tea, cola, milk tea, etc.) within 48 hours before dosing, or other special diet that can affect drug absorption, distribution, metabolism and excretion;
8
Injection site assessment
Timeframe: Collected from signing of informed consent until 90 days after a single dose.