RecruitingPhase 1Phase 2NCT07185815

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

A Prospective, Dose Escalating, Open Label, Multi-center, Phase I/IIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.


Sponsor

Mapi Pharma Ltd.

Enrollment

24 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new long-acting injectable form of cariprazine (a medication used for schizophrenia and mood disorders). Rather than taking a daily pill, participants would receive a subcutaneous injection every few weeks. The goal is to compare how the body processes the injectable versus the oral form. **You may be eligible if...** - You are aged 18–64 with a diagnosis of schizophrenia, bipolar I disorder, or major depressive disorder - You are currently stable on another antipsychotic or antidepressant medication - Your symptoms are well-controlled (CGI-S score of 0–4) - Your BMI is between 18.5 and 35 **You may NOT be eligible if...** - You have schizoaffective disorder, dementia, or severe personality disorder - You have a history of heart or blood vessel disease - You have a history of seizures - You participated in another clinical trial drug study in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCariprazine Depot

One single dose of 22 mg

DRUGCariprazine Depot

One single dose of 44 mg

DRUGCariprazine Depot MTD

Three monthly doses of MTD (maximum tolerated dose)

DRUGOral Cariprazine 3 mg/day

Oral Cariprazine 3 mg/day for three months


Locations(6)

Mapi Pharma Investigational Site IN-101

Ahmedabad, India

Mapi Pharma Investigational Site IN-102

Ahmedabad, India

Mapi Pharma Investigational Site IL-004

Beersheba, Israel

Mapi Pharma Investigational Site IL-003

Ness Ziona, Israel

Mapi Pharma Investigational Site IL-005

Ramat Gan, Israel

Mapi Pharma Investigational Site IL-001

Tel Aviv, Israel

View Full Details on ClinicalTrials.gov

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NCT07185815


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