MedTrace Logo

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

NCT07185815 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

Interventions

DRUG

Cariprazine Depot

One single dose of 22 mg

DRUG

Cariprazine Depot

One single dose of 44 mg

DRUG

Cariprazine Depot MTD

Three monthly doses of MTD (maximum tolerated dose)

DRUG

Oral Cariprazine 3 mg/day

Oral Cariprazine 3 mg/day for three months

Sponsors & Collaborators

  • Mapi Pharma Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-31
Completion
2027-06-03

Countries

  • India
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185815 on ClinicalTrials.gov