CTRI/2025/02/081389Active, not recruitingPhase 1
An Open-Label, Multi-Center, Single-Arm, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of B2227 Extended-Release Injectable Suspension 90 mg in Subjects with Schizophrenia.
Bostal Drug Delivery Co., Ltd.2 sites in 1 country12 target enrollmentStarted: March 4, 2025Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- To assess the Pharmacokinetics, Safety and Tolerability of bi-monthly B2227 ER Injectable Suspension 90 mg, for subcutaneous use in subjects with Schizophrenia.
Study Overview
Brief Summary
An Open-Label, Multi-Center, Single-Arm, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of B2227 Extended-Release Injectable Suspension 90 mg in Subjects with Schizophrenia
Primary Objective: To assess the PK, safety and tolerability of bi-monthly B2227 ER Injectable Suspension 90 mg, for subcutaneous use in subjects with Schizophrenia.
Secondary Objective: To monitor the adverse events and to ensure the safety of subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects who meet all of the following criteria will be eligible to participate in this study:
- •Subjects and/or subjects legally acceptable representative (LAR) is able to sign informed consent and subject is willing to comply with the trial protocol and to attend the clinic visits.
- •Male or female subjects diagnosed with schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) (or later) criteria.
- •Subjects with a Clinical Global Impression-Severity of Illness (CGI-S) Score of less than or equal to 4 at screening.
- •Subjects with Positive and Negative syndrome-scale (PANSS) total score less than or equal to75 at screening.
- •Subjects aged 18-65 years (both inclusive) having Body Mass Index (BMI) between 18.50 to 30.00 kg per m
- •Schizophrenic subjects who are clinically stable on their current antipsychotic medication other than cariprazine, for a duration of at least 8 weeks prior to screening.
- •NOTE: Subjects must NOT be taking greater than 2 antipsychotic medications for their disease.
- •Subjects who have previously received and tolerated oral cariprazine 3 mg or higher dose.
- •Subjects with acceptable hematology status: a.
- •Hemoglobin greater than or equal to 9 g per dL b.
- •Absolute neutrophil count (ANC) greater than or equal to 1500 cells per micro L c.
- •Platelet count greater than or equal to 100,000 cells per micro L d.
- •White blood cell count (WBC) greater than or equal to 4000 cells per micro L
- •Subjects with acceptable liver function: a.
- •Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN) b.
- •Aspartate aminotransferase (AST) less than or equal to 2X ULN c.
- •Bilirubin less than 1.2 mg per dL d.
- •Alkaline phosphatase less than or equal to 2X ULN
- •Subjects with creatinine clearance greater than or equal to 60 mL per minute (using the Cockcroft-Gault Equation).
- •Female subjects of childbearing potential with negative pregnancy test at screening and at enrollment day, and agree to practice acceptable methods of contraception during the study.
- •Acceptable methods of contraception for male and female subjects are: a.
- •Oral or other (eg.
- •injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication b.
- •Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) e.
- •Total abstinence, partial abstinence is not acceptable f.
- •Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
- •Male subjects must agree to use an effective method of contraception from screening until the duration of study and must agree not to donate sperm during the study treatment period until the end of study.
Exclusion Criteria
- •Subjects who meet any one of the following criteria will be excluded from the study:
- •Subjects with known hypersensitivity to cariprazine or related class of drugs or to any of the excipients of the formulation.
- •Subjects who have received oral cariprazine 3 mg or higher dose within 14 weeks prior to IP administration.
- •Subjects currently in acute, manic episodes of schizophrenia, as assessed by the Investigator.
- •Subjects with history of or a current DSM-V-TR diagnosis of concurrent mental disorder besides schizophrenia (eg.
- •schizoaffective-disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder).
- •Subjects who have any suicidal ideation based on history, routine psychiatric status examination, investigators judgment, or who have an answer of yes on any of the questions of ‘Suicidal Ideation’ on the C-SSRS for screening.
- •Subjects with history or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, Parkinson’s disease, epilepsy or other seizure disorders, cognitive and motor impairment, pathological gambling, dysphagia or other compulsive behavior.
- •Subjects with clinically significant dyslipidemia as per Investigators discretion.
- •Subjects with a history of syncope or a presence of significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 20 mm Hg or more and/or a drop in diastolic blood pressure of 10 mm Hg or more within 3 minutes of standing from supine) at screening.
- •Subjects with known history or presence of any uncontrolled systemic disease (eg.
- •cardiovascular disease, cerebrovascular disease, diabetes mellitus, etc.).
- •Subjects who have received concomitant medications that are strong CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to study drug administration (or within five half-lives since the last drug administration, whichever is greater), or is expected to require such treatment during the study.
- •Subjects with any other medical condition or serious inter-current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness other than schizophrenia /social situations that would limit adherence to study requirements.
- •Subjects found positive for urine screen for drugs of abuse (except for benzodiazepine, which is a permissible medication if supported by prescription).
- •Subjects with major surgical procedure (including periodontal) within 28 days of IP dosing or plan to have major surgical procedure during the study.
- •Subjects with current surgical or other non-healing wounds.
- •Subjects who have participated in any clinical trial with another investigational drug or other investigational intervention within 90 days of enrollment.
- •Loss of greater than or equal to 350 mL (1 unit) of blood within 90 days before enrollment in the study.
- •Subjects with history of difficulty with donating blood or difficulty in accessibility of veins.
- •Subjects with seropositive results for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •Alcoholics (alcohol consumption of more than 14 units per week for men and more than 7 units per week for women, each unit equivalent to 360 mL of beer or 150 mL of wine or 45 mL of spirits with 40% alcohol content) and those who have a positive urine alcohol test.
- •Subjects who have consumed tobacco-containing products (smoking, tobacco chewing, etc.), xanthine containing food, poppy seeds, and beverages (chocolates, tea, coffee, or cola drinks) or alcohol within 48.00 hours (02 days) prior to dosing.
- •Subjects who have consumed grapefruit or its juice and cranberry juice within 96.00 hours (04 days) prior to dosing.
- •Subjects currently smoking greater than or equal to 10 cigarettes or equivalent per day.
- •Pregnant or lactating women.
Outcomes
Primary Outcomes
To assess the Pharmacokinetics, Safety and Tolerability of bi-monthly B2227 ER Injectable Suspension 90 mg, for subcutaneous use in subjects with Schizophrenia.
Time Frame: Day 01(Pre Dose 00.00hrs),Day01,02,04,06,09,12, 15,19,22,25, 29,36 ,43,50,57,64,71,78,85,92,99,106,120,134 (Post Dose 0.25hrs, 0.50hrs,1.00hrs,2.00hrs, 4.00hrs,8.00hrs,24.00hrs,72.00hrs,120.00hrs,192.00hrs, 264.00hrs, 336.00hrs,432.00hrs,504.00hrs,576.00hrs,672.00hrs,840.00hrs,1008.00hrs, 1176.00hrs,1344.00hrs,1572.00hrs,1680.00hrs,1848.00hrs,2016.00hrs,2184.00hrs, | 2352.00hrs,2520.00hrs,2856.00hrs,3192.00hrs)
Secondary Outcomes
- To monitor the adverse events & to ensure the safety of subjects.(Day 01(Pre Dose 00.00hrs),Day01,02,04,06,09,12, 15,19,22,25, 29,36,43,50,57,64,71,78,85,92,99,106,120,134 (Post Dose 0.25hrs, 0.50hrs,1.00hrs,2.00hrs,4.00hrs,8.00hrs,24.00hrs,72.00hrs,120.00hrs,192.00hrs, 264.00hrs,336.00hrs,432.00hrs,504.00hrs,576.00hrs,672.00hrs,840.00hrs,1008.00hrs,1176.00hrs,1344.00hrs,1572.00hrs,1680.00hrs,1848.00hrs,2016.00hrs,2184.00hrs,)
Investigators
Dr Sandeep Singh
CBCC Global Research
Study Sites (2)
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