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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

NCT07185815 · tracked via the Priya Life Science Israel tracker
Sponsor
Mapi Pharma Ltd
Phase
Phase 1/2
Started
2025-08-01
Last updated
2026-05-01

Condition(s) studied

SchizophreniaBipolar I DisorderMajor Depressive Disorder

Investigational drug(s) / intervention(s)

Cariprazine DepotCariprazine DepotCariprazine Depot MTDOral Cariprazine 3 mg/day →

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

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07185815 on ClinicalTrials.gov ↗ ← All trials in Israel