Recruiting
Phase 1/2
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
Condition(s) studied
SchizophreniaBipolar I DisorderMajor Depressive Disorder
Investigational drug(s) / intervention(s)
Cariprazine Depot: One single dose of 22 mg
Cariprazine Depot: One single dose of 44 mg
Cariprazine Depot MTD: Three monthly doses of MTD (maximum tolerated dose)
Oral Cariprazine 3 mg/day: Oral Cariprazine 3 mg/day for three months
Study summary
The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine.
Eligibility
Key Inclusion Criteria:
* Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only).
* Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic/s or antidepressant/s other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg/day, with CGI-S score of 1-4.
* Men and women aged 18-64 years (inclusive).
* Body mass index (BMI) 18.5-35.
* Able to sign an informed consent form.
* Adult subjects with a current diagnosis of schizophrenia, who meet DSM-5-TR diagnostic criteria for schizophrenia, naïve to or treated with antipsychotics (this inclusion criterion relates to cohort 3 only).
Key Exclusion Criteria:
* Subjects with schizophrenia with PANSS item scores of \> 4 on any of the following: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.
* Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.
* Use of an investigational drug, and/or participation in clinical studies with an investigational product within 3 months prior to screening.
* History or current cardiovascular or cerebrovascular disease.
* History of seizures or conditions that lower the seizure threshold.
* Use of concomitant administration of strong or moderate CYP3A4 inhibitors.
* Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated.
* Subjects with Suicidal Thoughts and Behaviors or has a history of suicidal ideation in the past year, or made a suicide attempt in the past 5 years.
* Subjects with a history of orthostatic hypotension and/or syncope.
* Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).
* Subjects with CGI-S score of 5-7.
* Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.
* For cohort 3 only: Subjects treated with oral Clozapine.
Primary outcome measure(s)
- Safety, rate of adverse events (AEs) — Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort
- Plasma concentration of cariprazine and its active metabolites (DCAR, DDCAR) — Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort
Trial sites (6)
| Facility | City | Region | Status |
| Mapi Pharma Investigational Site IN-101 |
Ahmedabad |
India |
Recruiting |
| Mapi Pharma Investigational Site IN-102 |
Ahmedabad |
India |
Recruiting |
| Mapi Pharma Investigational Site IL-004 |
Beersheba |
Israel |
Recruiting |
| Mapi Pharma Investigational Site IL-003 |
Ness Ziona |
Israel |
Recruiting |
| Mapi Pharma Investigational Site IL-005 |
Ramat Gan |
Israel |
Recruiting |
| Mapi Pharma Investigational Site IL-001 |
Tel Aviv |
Israel |
Recruiting |
More Mapi Pharma Ltd. trials in Israel
Other trials for the same condition