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Tests treatment safety and results for Schizophrenia Disorders
Official title 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.
ClinicalTrials.gov ID: NCT06674694
What this study is testing
What is Brexpiprazole long-acting injection?
Brexpiprazole long-acting injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for schizophrenia disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Volunteers:
- Male and female people aged 18 to 65 years (including) at the time of signing the informed consent (the number of single sex in each group is not...
- 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;
- people of childbearing potential (including partners) have no pregnancy plan or sperm donation and egg donation plan since signing the informed...
- Sign informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
You likely can't join if
- Healthy Volunteers:
- History of cardiovascular system (such as history of ischemic heart disease), endocrine system, urinary system, nervous system, hematology...
- Physical examination, vital signs, 12-lead electrocardiogram, clinical laboratory tests (including hematology, urinalysis, serum biochemistry...
- 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...
See the full eligibility criteria
Who can join
- Healthy Volunteers:
- Male and female people 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;
- people 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...
- Sign informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- people can communicate well with the investigator, and understand and comply with the requirements of this study. Patients with schizophrenia:
- Male and female people 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;
- people need to complete the tolerance test according to the protocol requirements;
- people 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...
- people and their guardians signed informed consent;
- people and their guardians agree to comply with the protocol and cooperate with the investigator to complete the trial.
What rules you out
- Healthy Volunteers:
- 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...
- Physical examination, vital signs, 12-lead electrocardiogram, clinical laboratory tests (including hematology, urinalysis, serum biochemistry, thyroid panel, coagulation panel, serum prolactin, virological examination...
- 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...
- 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...
- 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...
- Those who drink excessive amounts (more than 8 cups, 1 cup = 250 mL) of tea or coffee or beverages rich in xanthine/caffeine/grapefruit (such as milk tea, cola, fruit juice, etc.) before administration;
- Previous alcohol abuse (i.e., men drink more than 28 standard units per week, women drink more than 21 standard units per week (1 standard unit contains 14 g alcohol, such as 360 mL beer or 45 mL spirits with 40%...
- Those who smoke more than 3 cigarettes per day within 3 months before dosing, or are unwilling to stop using any tobacco products from the date of screening to the last PK blood collection in the trial;
- Those with a history of drug dependence or a history of drug abuse;
- Positive urine drug abuse screening;
- Alcohol breath test positive;
- Those who donate blood or transfuse blood products or use blood products within 1 month before administration (\> 200 mL);
- Those who have undergone surgery within 1 month before administration, or who plan to undergo surgery from the date of screening to the last PK blood collection period of the trial;
- Those who are allergic or allergic to any component of this product and excipients (allergic to two or more drugs or food);
- History of needle sickness or blood sickness with clinical significance judged by the investigator to;
- Pregnant or lactating women;
- Those who have unprotected sex within 2 weeks prior to administration;
- The investigator judged that it was not suitable to participate in this trial. Patients with schizophrenia:
- Patients with other psychiatric diseases other than schizophrenia diagnosed according to ICD-10 (except the diagnosis of concomitant symptoms of schizophrenia);
- 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...
- Those who have taken any brexpiprazole tablets for tolerance testing within 28 days prior to oral tolerance test drugs (brexpiprazole tablets);
- Those who have been enrolled in the clinical trial of brexpiprazole long-acting injection and received the test drug administration;
- More than 1 other antipsychotic drug was used before administration (except for the brexpiprazole tablets given for tolerance testing, which can be combined with ≤ 1 other antipsychotic drug and the drug has been...
- Those who have received other antipsychotic long-acting injection treatment and the interval from the first dose is shorter than that of the long-acting injection;
- Patients with clinically significant cardiovascular and cerebrovascular diseases, including but not limited to: Concomitant cardiac insufficiency, Severe arrhythmias requiring treatment, Ischemic heart disease requiring...
- Patients with poorly controlled diabetes (HbA1c ≥ 7.0%);
- Pre-dose hematopoiesis and major organ function indicators meet any of the following criteria: White blood cell count \ 2 times the upper limit of normal, alanine aminotransferase \> 2 times the upper limit of normal...
- Previous alcohol abuse (i.e., men drink more than 28 standard units per week, women drink more than 21 standard units per week (1 standard unit contains 14 g alcohol, such as 360 mL beer or 45 mL spirits with 40%...
- Those who drink excessive amounts (more than 8 cups, 1 cup = 250 mL) of tea or coffee or beverages rich in xanthine/caffeine/grapefruit (such as milk tea, cola, fruit juice, etc.) before administration;
- Those who smoke more than 3 cigarettes per day within 3 months before dosing, or are unwilling to stop using any tobacco products from the date of screening to the last PK blood collection in the trial;
- Alcohol breath test positive;
- Those with a history of drug dependence or a history of drug abuse;
- Positive urine drug abuse screening;
- Those who donate blood or transfuse blood products or use blood products within 1 month before administration (\> 200 mL);
- Those who have undergone surgery within 1 month before dosing, or who plan to undergo surgery from the date of screening to the last PK blood collection period of the trial;
- Patients with Parkinson's disease, malignant syndrome or dementia-related psychosis;
- Previous or current tardive dyskinesia (the 8th item score of the involuntary movement scale (AIMS) ≥ 3) or severe akathisia (BARS) overall clinical assessment score of 5 points;
- Patients with epilepsy or convulsive diseases (except febrile convulsions);
- people with severe suicidal tendency: the fourth and fifth items of "suicidal ideation" in the Columbia Suicide Severity Rating Scale (C-SSRS) answered "Yes" and the most recent episode within 6 months met the...
- Have a history of needle sickness or blood sickness, and judged by the investigator to have clinical significance;
- Those who are allergic or allergic to any component of this product and excipients (allergic to two or more drugs or food);
- Those who have received electroconvulsive therapy within 14 days prior to screening;
- Positive for HBsAg, HCV-Ab, Anti-HIV, syphilis antibody;
- Pregnant or lactating women;
- Those who have unprotected sex within 2 weeks prior to dosing;
- Those who have used the following drugs or food before administration: Received any prescription of traditional Chinese medicine preparations, including traditional Chinese medicine, Chinese herbal decoction pieces...
- The investigator judged that it was not suitable to participate in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.