NCT07185815View on ClinicalTrials.gov

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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

June 3, 2027

Conditions
Major Depressive Disorder (MDD)Bipolar 1 DisorderSchizophrenia
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

Trial Locations (1)

6423906

RECRUITING

Tel Aviv, Israel, Tel Aviv

Sponsors

Lead Sponsor

Mapi Pharma Ltd.
All Listed Sponsors
lead

Mapi Pharma Ltd.

INDUSTRY

NCT07185815 - Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine | Biotech Hunter | Biotech Hunter