Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Cariprazine 90 mg ER injection: Dose: 90 mg,
Frequency: Once,
Route of Administration: Subcutaneous (SC) injection,
Duration of Therapy: Upto 162 days.
Control Intervention1: NA: NIL
Sponsors
Bostal Drug Delivery Co., Ltd.
CBCC Global Research
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be eligible to participate in this study: 1. 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. 2. 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. 3. Subjects with a Clinical Global Impression-Severity of Illness (CGI-S) Score of less than or equal to 4 at screening. 4. Subjects with Positive and Negative syndrome-scale (PANSS) total score less than or equal to75 at screening. 5. Subjects aged 18-65 years (both inclusive) having Body Mass Index (BMI) between 18.50 to 30.00 kg per m2. 6. 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. 7. Subjects who have previously received and tolerated oral cariprazine 3 mg or higher dose. 8. 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 9. 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 10. Subjects with creatinine clearance greater than or equal to 60 mL per minute (using the Cockcroft-Gault Equation). 11. 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. Intrauterine device or intrauterine system c. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) d. 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 12. Subjects who agree to avoid drinking alcohol during the study. 13. 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
Exclusion criteria: Subjects who meet any one of the following criteria will be excluded from the study: 1. Subjects with known hypersensitivity to cariprazine or related class of drugs or to any of the excipients of the formulation. 2. Subjects who have received oral cariprazine 3 mg or higher dose within 14 weeks prior to IP administration. 3. Subjects currently in acute, manic episodes of schizophrenia, as assessed by the Investigator. 4. 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). 5. 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. 6. 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. 7. Subjects with a prior personal or family history of dystonic reactions to medications. 8. Subjects with clinically significant dyslipidemia as per Investigators discretion. 9. 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. 10. Subjects with known history or presence of any uncontrolled systemic disease (eg. cardiovascular disease, cerebrovascular disease, diabetes mellitus, etc.). 11. Subjects who are on concurrent treatment with other anti-psychotic Long-acting Injection (LAIs). 12. 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. 13. 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. 14. Any other condition(s), which could significantly interfere with protocol compliance. 15. Subjects found positive for urine screen for drugs of abuse (except for benzodiazepine, which is a permissible medication if supported by prescription). 16. Subjects with major surgical procedure (including periodontal) within 28 days of IP dosing or plan to have major surgical procedure during the study. 17. Subjects with current surgical or other non-healing wounds. 18. Subjects who have participated in any clinical trial with another investigational drug or other investigational intervention within 90 days of enrollment. 19. Loss of greater than or equal to 350 mL (1 unit) of blood within 90 days before enrollment i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Pharmacokinetics, Safety and Tolerability of bi-monthly B2227 ER Injectable Suspension 90 mg, for subcutaneous use in subjects with Schizophrenia.Timepoint: 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
| Measure | Time frame |
|---|---|
| To monitor the adverse events & to ensure the safety of subjects.Timepoint: 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) | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research
Outcome results
None listed