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.
Study ID
NCT07185815
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 3, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2
  • Experimental: Cohort 3

Primary Outcome Measure

Safety, rate of adverse events (AEs) [ Time Frame: 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 ]

Central Contacts

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